Manifold for respiratory device

ABSTRACT

A respiratory device includes a blower having an inlet and an outlet, a patient interface, and a valve including a valve member that is rotatable through a first angular displacement in a first direction from a first position to a second position. The outlet of the blower is coupled to the patient interface so that positive pressure is provided to a patient&#39;s airway via the patient interface when the valve member is in the first position. The inlet of the blower is coupled to the patient interface so that negative pressure is provided to the patient&#39;s airway via the patient interface when the valve member is in the second position. The valve member is rotatably oscillated back and forth when the valve member is in the first position and when the valve member is in the second position so that oscillations in the positive pressure and negative pressure, respectively, are provided to the patient&#39;s airway.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a U.S. national phase of PCT/SG2016/050166, filed onApr. 1, 2016, which claims priority, under 35 U.S.C. § 119(a), ofMalaysian Patent Application No. PI 2015000844 which was filed Apr. 2,2015 and which is hereby incorporated by reference herein. The presentapplication also claims the benefit, under 35 U.S.C. § 119(e), of U.S.Provisional Patent Application No. 62/170,335 which was filed Jun. 3,2015 and which is hereby incorporated by reference herein.

BACKGROUND

The present disclosure relates to respiratory devices and particularly,to manifolds for respiratory therapy devices. More particularly, thepresent disclosure relates to respiratory devices that are operable toapply varying levels of oscillating pressure to an airway of a patient.

Respiratory devices that provide positive pressure to a person's airwayare known. For example, there are Continuous Positive Airway Pressure(CPAP) devices that apply positive pressure to a person's airway at asubstantially constant level during the person's inhalation andexhalation. There are also Bi-Level CPAP devices that apply varyinglevels of positive pressure to a person, such as applying a first amountof positive pressure during inhalation and a second amount of positivepressure during exhalation.

Respiratory devices that provide negative pressure or suction to aperson's airway are also known. One category of such devices ismechanical insufflation/exsufflation (MIE) devices. These devices aresometimes referred to as cough assist devices. This is becauseapplication of positive pressure followed by application of negativepressure to a person's airway simulates a cough and assists the personin expelling mucus from their airway. One such known cough assist deviceis the VITALCOUGH™ System available from Hill-Rom Company, Inc. In thisregard, see U.S. Pat. No. 8,539,952 which is hereby incorporated byreference herein.

Respiratory devices that are capable of applying both positive andnegative pressure to a person's airway sometimes have a pressure source,such as a blower, and at least one valve that changes position toselectively connect either the outlet of the blower or the inlet of theblower to a patient interface, such as a mask or mouthpiece and relatedtubing, to apply the positive pressure or the negative pressure,respectively to the person's airway. Other respiratory devices haveseparate positive pressure and negative pressure sources.

Some respiratory devices include additional structural elements, such asone or more valves, diaphragm pumps, acoustic devices, or piezoelectricdevices that operate to provide oscillations in the baseline pressurelevels being applied to the person's airway. These additional structuralelements to produce the oscillations add cost, size and weight to therespiratory device. Patients and caregivers, therefore, may appreciaterespiratory devices capable of producing oscillatory pressures, such aspositive pressures or negative pressures or both, but that are smaller,less expensive, and lighter in weight than known respiratory devices.

SUMMARY

An apparatus, system, or method may comprise one or more of the featuresrecited in the appended claims and/or the following features which,alone or in any combination, may comprise patentable subject matter:

A respiratory device may include a blower that may have an inlet and anoutlet, a patient interface, and a valve that may include a valve memberthat is rotatable through a first angular displacement in a firstdirection from a first position to a second position. The outlet of theblower may be coupled to the patient interface so that positive pressuremay be provided to a patient's airway via the patient interface when thevalve member is in the first position. The inlet of the blower may becoupled to the patient interface so that negative pressure may beprovided to the patient's airway via the patient interface when thevalve member is in the second position. The valve member may berotatably oscillated back and forth through a second angulardisplacement that may be smaller than the first angular displacement inthe first direction and a second direction opposite to the firstdirection when the valve member is in the first position and when thevalve member is in the second position so that oscillations in thepositive pressure and negative pressure, respectively, may be providedto the patient's airway.

In some embodiments, the first angular displacement may be less than90°, such as optionally being about 22.5°. The second angulardisplacement may be about 10°, for example. A frequency of oscillationof the valve member may be adjustable between about 1 Hertz and about 20Hertz. The respiratory device may have a motor that may be operable torotate and oscillate the valve member. The motor may include a steppermotor, for example.

In some embodiments, the valve member may include a rotatable plate andthe valve may include a pair of stationary plates between which therotatable plate may be sandwiched. The rotatable plate may have acircular outer periphery, for example. The valve may further include anannular shim that may be situated between the pair of stationary platesand that may surround the outer periphery of the rotatable plate.

If desired, the stationary plates may have four holes. A center of eachhole of the four holes of the stationary plates may be spaced fromanother center of the four holes by about 90° around an axis about whichthe rotatable plate may rotate. The rotatable plate may have four holesgrouped into pairs of holes. A center of each hole of the pair of holesof the rotatable plate may be spaced from a center of the other hole ofthe pair by about 45° around the axis. A first plate of the pair ofstationary plates may have a first hole and a second hole of its fourholes pneumatically coupled to the inlet of the blower and may have athird hole and fourth hole of its four holes pneumatically coupled tothe outlet of the blower.

In some embodiments, when the rotatable plate is in the first position,a first hole of the four holes of the rotatable plate may be alignedwith the first hole of the first stationary plate and a solid portion ofthe rotatable plate may block the second hole of the first stationaryplate. When the rotatable plate is in the second position, the firsthole of the first stationary plate may be blocked by another solidportion of the rotatable plate and a second hole of the rotatable platemay be aligned with the second hole of the first stationary plate.

According to this disclosure, when the rotatable plate is in the firstposition, a third hole of the rotatable plate may be aligned with thethird hole of the first stationary plate and another solid portion ofthe rotatable plate may block the fourth hole of the first stationaryplate. When the rotatable plate is in the second position, the thirdhole of the first stationary plate may be blocked by yet another solidportion of the rotatable plate and a fourth hole of the rotatable platemay be aligned with the fourth hole of the first stationary plate.

In some embodiments, a second plate of the pair of stationary plates mayhave a first hole and a second hole of its four holes pneumaticallycoupled to the patient interface and may have a third hole and fourthhole of its four holes pneumatically coupled to atmosphere. When therotatable plate is in the first position, a first hole of the four holesof the rotatable plate may be aligned with the first hole of the secondstationary plate and a solid portion of the rotatable plate may blockthe second hole of the second stationary plate. When the rotatable plateis in the second position, the first hole of the second stationary platemay be blocked by another solid portion of the rotatable plate and asecond hole of the rotatable plate may be aligned with the second holeof the second stationary plate.

According to this disclosure, when the rotatable plate is in the firstposition, a third hole of the rotatable plate may be aligned with thethird hole of the second stationary plate and another solid portion ofthe rotatable plate may block the fourth hole of the second stationaryplate. When the rotatable plate is in the second position, the thirdhole of the second stationary plate may be blocked by yet another solidportion of the rotatable plate and a fourth hole of the rotatable platemay be aligned with the fourth hole of the second stationary plate.

In some embodiments, the valve member may include a rotatable spool thatmay be located within a stationary cylinder. The rotatable spool mayhave a first set of holes and the stationary cylinder may have a secondset of holes. A first subset of the first set of holes of the rotatablespool may align with a first subset of the second set of holes of thestationary cylinder when the rotatable spool is in the first positionand a second subset of holes of the second holes may be blocked by solidportions of the rotatable spool. A second subset of the first set ofholes of the rotatable spool may align with the second subset of thesecond set of holes of the stationary cylinder when the rotatable spoolis in the second position and the first subset of holes of the secondholes may be blocked by other solid portions of the rotatable spool.

In some embodiments, a speed of the blower may be controlled so that thepositive pressure provided to the airway of the patient maysubstantially match a positive target pressure that may be selected by auser and so that the negative pressure provided to the airway of thepatient may substantially match a negative target pressure that may beselected by the user. The blower speed may be controlled so that apositive rest pressure, less than the positive target pressure, may beprovided to the airway of the patient after the negative target pressureis applied to the airway of the patient and before the next positivetarget pressure is applied to the airway of the patient. The blowerspeed may be controlled so that a sigh pressure is applied to the airwayof the patient at the end of a therapy session, the sigh pressure beinggreater than the positive rest pressure but less than the positivetarget pressure.

The respiratory device may further include a sensor that may sense abeginning of an inspiration of the patient and control circuitry coupledto the sensor and to the valve. The control circuitry may signal thevalve to move to the first position in response to the sensor sensingthe beginning of the inspiration of the patient. The control circuitrymay signal the blower to operate to provide the positive pressure to theairway of the patient at a positive target pressure. The sensor maycomprise a pressure sensor or a flow sensor or both, for example.

In some embodiments, the control circuitry may be programmable with apause time during which sensing of the beginning of an inspiration ofthe patient may be ignored by the control circuitry and the controlcircuitry may signal the blower to operate to provide a rest pressure tothe airway of the patient. The rest pressure may be a positive pressurethat is less than the positive target pressure, for example.

In some embodiments, the valve member may be bow-tie shaped.Alternatively or additionally, the respiratory device may furtherinclude a third stationary plate that may be situated between the secondstationary plate and the rotatable plate. In such embodiments, at leastone spring may be situated between the second stationary plate and thethird stationary plate to bias the third stationary plate against therotatable plate. In some embodiments, each of the stationary plates mayhave four holes and the third stationary plate may be formed to includefour tubular portions. Each tubular portion may be in registry with arespective hole of the four holes of the second stationary plate.Optionally, the at least one spring may include four springs. Eachspring of the four springs may be mounted on a respective tubularportion of the four tubular portions.

In some contemplated embodiments, the second stationary plate mayinclude an annular rim that may surround a first outer periphery of thethird stationary plate and a second outer periphery of the rotatableplate. In some such embodiments, the second stationary plate may includean annular flange that may project radially from the annular rim. Theannular flange may be fastened to the first stationary plate.

The respiratory device may further include control circuitry coupled tothe blower and to the valve and may further include a graphical userinterface (GUI) coupled to the control circuitry. Optionally, one ormore of the following may be coupled to the control circuitry: a portfor connection to a wireless communication module, a universal serialbus (USB) port, and a port for connection to a pulse oximetry device. Insome embodiments, the GUI may be operable to display one or more of thefollowing: peak flow information, pressure information, flowinformation, volume information, a pressure graph, a volume graph, aflow graph, a flow vs. volume graph, and a pressure vs. time graph.

According to this disclosure, the respiratory device may further includea wireless communication module that may be operable to transmit datawirelessly from the respiratory device. The wireless communicationmodule may operate according to the Bluetooth protocol, if desired. Thewireless communication module may receive information wirelessly andprovide the information to the control circuitry of the respiratorydevice.

The respiratory device may further include a housing in which the blowerand valve are housed and a hose connector that may be coupled to thehousing. The hose connector may be configured to retain a hose of thepatient interface adjacent the housing when the patient interface is notin use. In some embodiments, the housing may include a handle and thehose connector may include a hook extending from a back of the handle.In some embodiments, the housing may include a top wall and the hoseconnector may comprise a hose clip coupled to the top wall. Therespiratory device may include a power cord extending from the housingand the hose clip may be configured as a cord wrap around which thepower cord may be wrapped when not in use.

According to this disclosure, the respiratory device may further includea port pneumatically coupled to the valve and an adapter that mayinterconnect the port with a hose of the patient interface. Therespiratory device may include a housing in which the blower and valveare housed and a carrying case in which the housing may fit. Thecarrying case may have a section with a door that may be openable toprovide access to user controls on the housing without the need toremove the housing from the case. In some embodiments, the door maypivot upwardly from a closed position to an open position to expose theuser controls for use. In some embodiments, the door may pivotdownwardly from a closed position to an open position to expose the usercontrols for use. Optionally, the carrying case may be configured forattachment to a wheel chair.

According to an aspect of this disclosure, a respiratory device mayinclude a blower that may have an inlet and an outlet, a patientinterface, and a valve that may include a valve member that may beoperable to oscillate by cyclically rotating through an angulardisplacement in a first direction and in a second direction opposite tothe first direction. The blower may be operable to produce an inhalationpressure, an exhalation pressure that may be less than the inhalationpressure, and a rest pressure that may be less than the inhalationpressure and more than the exhalation pressure. The valve member may beoperable to oscillate during the application of the inhalation pressure,the exhalation pressure and the rest pressure so that oscillations inthe inhalation pressure, the exhalation pressure, and the rest pressurerespectively, may be provided to the patient's airway.

In some embodiments, the angular displacement may be less than 90°, suchas possibly being less than 22.5°, for example. It is contemplated thatthe angular displacement may be about 10°, if desired. A frequency ofoscillation of the valve member may be adjustable between about 1 Hertzand about 20 Hertz in some embodiments. The respiratory device mayfurther have a motor that may be operable to rotate and oscillate thevalve member. The motor may comprise a stepper motor, for example.

According to another aspect of this disclosure, a respiratory device mayinclude a blower that may have an inlet and an outlet, a patientinterface, a valve that may be coupled to the blower and that may beoperable to control a pressure applied to the patient interface, asensor that may sense at least one of pressure and flow applied to thepatient interface, and control circuitry that may be coupled to theblower, the valve, and the sensor. The control circuitry operating theblower and the valve to apply a first threshold pressure to the patientinterface for a first preset amount of time in response to aninspiratory trigger being sensed by the sensor, the control circuitryoperating the blower and the valve to apply a second threshold pressureto the patient interface during a rest phase that occurs after the firstpreset amount of time, the control circuitry operating to ignore one ormore inspiratory triggers that are sensed by the sensor and that occurduring the rest phase.

In some embodiments, the control circuitry may operate the blower andthe valve to apply a third threshold pressure for a second preset amountof time after the first preset amount of time and before the rest phasebut this need not be the case. It is contemplated that the firstthreshold pressure may comprise a first positive pressure and the secondthreshold pressure may comprise a negative pressure. It is alsocontemplated that the second threshold pressure may comprise a secondpositive pressure that may be less than the first positive pressure.

According to this disclosure, the valve may be selectively coupleable tothe blower inlet and the blower outlet so that positive pressure andnegative pressure may be selectively applied to the patient interface.If desired, the valve may be operable to oscillate the positive pressureand the negative pressure applied to the patient interface. The valvemay include a rotatable plate that may be rotated through a firstangular displacement to change between application of the positivepressure to the patient interface and application of the negativepressure to the patient interface. The rotatable plate may be moved backand forth through a second angular displacement to oscillate thepositive pressure and the negative pressure. The second angulardisplacement may be less than the first angular displacement.

In some embodiments, the valve may include a rotatable spool that may berotated through a first angular displacement to change betweenapplication of the positive pressure to the patient interface andapplication of the negative pressure to the patient interface. Therotatable spool may be moved back and forth through a second angulardisplacement to oscillate the positive pressure and the negativepressure. The second angular displacement may be less than the firstangular displacement.

In some embodiments, the control circuitry may ignore a preset number ofinspiratory triggers sensed by the sensor during the rest phase and thenmay operate the blower and the valve to reapply the first thresholdpressure in response to the next inspiratory trigger sensed by thesensor after the preset number of inspiratory triggers were ignored.Alternatively or additionally, the rest phase may last for at least apreset rest duration and the control circuitry may operate the blowerand the valve to reapply the first threshold pressure in response to thenext inspiratory trigger sensed by the sensor after the preset duration.

In some embodiments, the control circuitry may operate the blower andthe valve so that a sigh pressure may be applied to the patientinterface at the end of a therapy session. The sigh pressure may bedifferent than the first threshold pressure and may be different thanthe second threshold pressure. For example, the sigh pressure may beless than the first threshold pressure and greater than the secondthreshold pressure.

According to an aspect of this disclosure, a respiratory device mayinclude a pressure source to produce pressure to be applied to apatient's airway, a housing that may contain the pressure source, anoutlet port that may be accessible on the housing, and at least onepatient interface that may be configured to be coupled to the outletport. The patient interface may include a filter unit that may includean air filter carrier and at least one prong that may extend from theair filter carrier. The respiratory device may have at least one switchthat may be situated in the housing. The housing may have at least oneprong-receiving aperture adjacent the outlet port. The at least oneprong may extend through the aperture and may activate the switch whenthe respective patient interface is coupled to the outlet port. Thepressure source may be disabled from operation unless the at least oneswitch is activated.

In some embodiments, the at least one patient interface may include afirst patient interface and a second patient interface. The at least oneprong of the first patient interface may have only one prong and the atleast one prong of the second patient interface may have two prongs. Theat least one switch may include first and second switches and the atleast one prong-receiving aperture may include first and secondapertures. The respiratory device may have a controller that maydistinguish whether the first patient interface or the second patientinterface is coupled to the outlet port based on how many of the firstand second switches are activated. Thus, in some embodiments, it iscontemplated that therapy mode options that may be delivered through theoutlet port may be different depending upon which of the first andsecond patient interfaces are coupled to the outlet port.

In some embodiments having a first patient interface and a secondpatient interface, the at least one prong of the first patient interfacemay include only two prongs and the at least one prong of the secondpatient interface may include three prongs. In such embodiments, the atleast one switch may include first, second, and third switches and theat least one prong-receiving aperture may include first, second andthird apertures. Further in such embodiments, the respiratory device mayinclude a controller that may distinguish whether the first patientinterface or the second patient interface is coupled to the outlet portbased on how many of the first and second switches are activated. Thus,in these embodiments, therapy mode options delivered through the outletport may be different depending upon which of the first and secondpatient interfaces are coupled to the outlet port.

In some embodiments, the respiratory device may further include acontroller and a user input that may be operable to signal thecontroller to override the disabling of the pressure source when theswitch is not activated thereby to permit the pressure source to operateeven if the at least one switch is not activated. For example, the userinput may be an input on a graphical display screen such as one or moreicons or buttons.

According to a further aspect of the present disclosure, a handset for arespiratory device may include a generally banana-shaped tube that mayhave an upper surface that may be generally convex from end-to-end ofthe generally banana-shaped tube and a bottom surface that may begenerally concave from end-to-end of the generally banana-shaped tube.The generally banana-shaped tube may have opposite first and second openends and may have a nebulizer port that may be provided at an apex ofthe upper surface such that, in use, a nebulizer may extend upwardlyfrom a top of the handset.

In some embodiments, the handset may further include a plug that mayclose the nebulizer port when the nebulizer is absent. The nebulizerport may include a cylindrical wall that may project into an interiorregion of the generally banana-shaped tube. Alternatively oradditionally, the nebulizer port may include an annular ridge that mayextend upwardly from the apex of the upper surface.

In some embodiments, the handset may further have an aperture that mayextend through the generally banana-shaped tube adjacent the first openend of the generally banana-shaped tube. In such embodiments, thehandset may also have a ring that may be rotatable between a firstposition in which the aperture may be open to atmosphere and a secondposition in which the aperture may be closed.

In some embodiments, the ring may include a sleeve that may wrap arounda majority of a circumference of the generally banana-shaped tube inabutting rotative bearing engagement therewith and the ring may have anoffset portion that may be coupled to the sleeve and that may define achannel that aligns with the aperture when the ring is in the firstposition so that the aperture may communicate with atmosphere throughthe channel and that may be out of alignment with the aperture when thering is in the second position.

The generally banana-shaped tube may have first and second depressionsand the ring may include a flexible finger with a detent that may bereceived in the first depression when the ring is in the first positionand that may be received in the second depression when the ring is inthe second position. The generally banana-shaped tube may have acircumferential groove formed therearound and the sleeve of the ring mayinclude at least one tab that may project into the groove to retain thering on the generally banana-shaped tube.

In some embodiments, the ring may include a finger tab that may extendoutwardly from the offset portion of the ring. The finger tab may beusable to rotate the ring relative to the generally banana-shaped tubebetween the first and second positions. The aperture may include an openslot located at the upper surface. The slot may be oriented in alongitudinal dimension of the generally banana-shaped tube.

According to still a further aspect of this disclosure, a respiratorydevice may include a pressure source to produce pressure to be appliedto a patient's airway, a housing that may contain the pressure source,an outlet port that may be accessible on the housing, a valve that maybe situated pneumatically between the pressure source and the outletport, and at least one pressure sensor and at least one flow sensor tomeasure pressure and flow, respectively, in a flow path that may bebetween the valve and the outlet port. The respiratory device mayinclude a patient interface that may have a tube having a first end thatmay be coupled to the outlet port and a mask that may be coupled to asecond end of the tube. The respiratory device may also include acontroller that may receive signals from the pressure sensor and theflow sensor to determine an inspiratory trigger indicative that thepatient may have started to inhale. The pressure source or the valve orboth may be operationally adjusted in response to detection of theinspiratory trigger. Based on a flow sensor signal from the flow sensorthe controller may be configured to determine mask removal or maskleakage and to stop operation of the pressure source.

In some embodiments, the controller may determine mask removal bycomparing the flow sensor signal to an open flow threshold on aniterative basis. For example, at least fifty iterations of flow sensorsignal data point comparisons to the open flow threshold may be requiredbefore the operation of the pressure source may be stopped. Eachiteration may take about 5 milliseconds in some embodiments.

In some embodiments, the controller may determine mask leakage bycomparing the flow sensor signal to a leakage threshold on an iterativebasis. For example, at least fifty iterations of flow sensor signal datapoint comparisons to the leakage threshold may be required before theoperation of the pressure source may be stopped. Each iteration may takeabout 5 milliseconds in some embodiments. It is contemplated that, insome embodiments, mask leakage less than the leakage threshold andgreater than no leakage may result in continued operation of thepressure source.

Additional features, which alone or in combination with any otherfeature(s), such as those listed above and those listed in the claims,may comprise patentable subject matter and will become apparent to thoseskilled in the art upon consideration of the following detaileddescription of various embodiments exemplifying the best mode ofcarrying out the embodiments as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a perspective view of a respiratory device having a housing, apatient interface including a hose coupled to the housing at a hose portand a mask at an end of the hose, a foot switch having a connectorarranged for connection to an electrical connector of the housing, agraphical user interface (GUI) accessible on a front wall of the housingto control operation of the respiratory device, and a wirelesscommunication module coupled to a sidewall of the housing;

FIG. 2 is a front elevation view of the respiratory device of FIG. 1;

FIG. 3 is a rear elevation view of the respiratory device of FIG. 1;

FIG. 4 is a side perspective view of the respiratory device of FIG. 1;

FIG. 5 is a top plan view of the respiratory device of FIG. 1;

FIG. 6 is a perspective view of internal components of the respiratorydevice of FIG. 1 showing a blower, a rotary plate valve and manifoldassembly to the right of the blower, and a stepper motor to the right ofthe rotary plate valve and manifold assembly;

FIG. 7 is an exploded perspective view of the components of FIG. 6showing a blower on the left hand side of the figure, a stepper motor ona right hand side of the figure, first and second manifold blocksadjacent the blower and stepper motor, respectively, first and secondcircular stationary plates adjacent the first and second manifold blocksrespectively, a circular rotatable plate situated between the first andsecond circular stationary plates, an annular shim adjacent the circularrotatable plate, and the annular shim having a central circular openingthat receives the rotatable plate therein;

FIG. 8 is a partial exploded perspective view showing the rotatableplate and annular shim locate against the first manifold block, therotatable plate being in a first position, and showing a series ofarrows that indicate a flow of air from the atmosphere through themanifold blocks, blower and rotary plate valve toward a patientinterface during application of positive pressure during insufflation ofa patient;

FIG. 9 is a partial exploded perspective view, similar to FIG. 8,showing the rotatable plate and annular shim locate against the firstmanifold block, the rotatable plate being in a second position aftermoving through a first angular displacement from the first position, andshowing a series of arrows that indicate a flow of air from the patientinterface through the manifold blocks, blower and rotary plate valve toexhaust to atmosphere during application of negative pressure duringexsufflation of a patient;

FIG. 10 is a diagrammatic view showing, in an upper portion of the view,the rotatable plate being in a maximum open position relative to thestationary plates during application of a maximum amount of positivepressure from the blower to the patient and showing, in a lower portionof the view, a graph showing oscillatory positive pressure, negativepressure and rest pressure profiles with a dot on the oscillatorypositive pressure profile corresponding to the position of the rotatableplate in the upper portion of the view;

FIG. 11 is a diagrammatic view, similar to FIG. 10, showing, in an upperportion of the view, the rotatable plate being in an intermediateposition relative to the stationary plates during application of anintermediate or baseline amount of positive pressure from the blower tothe patient and showing, in a lower portion of the view, a graph similarto that of FIG. 10 but with a dot on the oscillatory positive pressureprofile corresponding to the intermediate position of the rotatableplate in the upper portion of the view;

FIG. 12 is a diagrammatic view, similar to FIGS. 10 and 11, showing, inan upper portion of the view, the rotatable plate being in a minimallyopen position relative to the stationary plates during application of aminimum amount of positive pressure from the blower to the patient andshowing, in a lower portion of the view, a graph similar to that ofFIGS. 10 and 11 but with a dot on the oscillatory positive pressureprofile corresponding to the minimally open position of the rotatableplate in the upper portion of the view;

FIG. 13 is a diagrammatic view showing, in an upper portion of the view,the rotatable plate being in a maximum open position relative to thestationary plates during application of a maximum amount of negativepressure from the blower to the patient and showing, in a lower portionof the view, a graph similar to that of FIGS. 10-12 but with a dot onthe oscillatory negative pressure profile corresponding to the positionof the rotatable plate in the upper portion of the view;

FIG. 14 is a diagrammatic view, similar to FIG. 13, showing, in an upperportion of the view, the rotatable plate being in an intermediateposition relative to the stationary plates during application of anintermediate or baseline amount of negative pressure from the blower tothe patient and showing, in a lower portion of the view, a graph similarto that of FIG. 13 but with a dot on the oscillatory negative pressureprofile corresponding to the intermediate position of the rotatableplate in the upper portion of the view;

FIG. 15 is a diagrammatic view, similar to FIGS. 13 and 14, showing, inan upper portion of the view, the rotatable plate being in a minimallyopen position relative to the stationary plates during application of aminimum amount of negative pressure from the blower to the patient andshowing, in a lower portion of the view, a graph similar to that ofFIGS. 13 and 14 but with a dot on the oscillatory negative pressureprofile corresponding to the minimally open position of the rotatableplate in the upper portion of the view;

FIG. 16 is a diagrammatic view similar to the upper portions of FIGS.10-15, showing the rotatable plate in a rest position in which bothpositive and negative pressure from the blower is applied to the patientinterface in roughly equal amounts to establish a zero baseline restpressure and a double headed arrow indicating that the rotatable plateis able to oscillate in back and forth in first and second directions tocreate oscillations above and below the zero baseline rest pressure;

FIG. 17 is a partial exploded perspective view of components of analternative embodiment of a portion of a respiratory device showing afirst manifold block carrying a blower, the first manifold block beingspaced above a second manifold block that supports a rotary spool valvehaving a stationary cylinder and rotatable cylinder or spool locatedwithin an interior region of the stationary cylinder, and the rotatablecylinder being coupled to a stepper motor located to the left of thefirst and second manifold blocks;

FIG. 18 is an exploded view of the components of FIG. 17 showing thestepper motor on the left hand side of the view, a circular couplingplate spaced to the right of stepper motor, a set of rotary couplersspaced to the right of the circular coupling plate, the rotatablecylinder spaced to the right of the rotary couplers, the stationarycylinder spaced to the right of the rotatable cylinder, the firstmanifold block spaced above the stationary cylinder, the second manifoldblock spaced beneath the stationary cylinder, and the blower spacedabove the first manifold block;

FIG. 19 is a partial exploded perspective view of the manifold blocks,blower, and rotary spool valve of FIGS. 17 and 18 showing the rotatablespool being in a first position relative to the stationary cylinder, andshowing a series of arrows that indicate a flow of air from theatmosphere through the manifold blocks to the blower and from the blowerthrough the rotary spool valve for exit toward the patient interfaceduring application of positive pressure during insufflation of thepatient;

FIG. 20 is a partial exploded perspective view similar to FIG. 19showing the rotatable spool being in a second position relative to thestationary cylinder, and showing a series of arrows that indicate a flowof air from the patient interface through the rotary spool valve to theblower and from the blower through the rotary spool valve for exit tothe atmosphere during application of negative pressure duringexsufflation of the patient;

FIG. 21 is a partial exploded perspective view similar to FIGS. 19 and20 showing the rotatable spool being in an intermediate position betweenthe first and second positions, and showing a series of arrows thatindicate that both positive and negative pressure components are appliedto the patient interface during application of a rest pressure to thepatient and showing a double headed arcuate arrow to indicate that therotatable spool is able to oscillate back and forth in first and seconddirections to produce oscillations in the pressure applied to thepatient interface;

FIG. 22 is an example of a screen shot of the GUI of FIG. 1 when therespiratory device is operating in an automatic mode;

FIG. 23 is a graph showing a pressure v. time curve showing a positiveinsufflation pressure (I-pressure), a negative exsufflation pressure(E-pressure), and a pause pressure (aka rest pressure) that is apositive pressure less than the I-pressure during which the patientbreaths spontaneously for multiple breaths;

FIG. 24 is a graph, similar to FIG. 23, but showing a sigh pressure atthe end of the treatment cycle, the sigh pressure being less than theI-pressure and greater than the pause pressure;

FIG. 25 is a graph, similar to FIG. 23, showing that the respiratorydevices of FIGS. 1-21 are capable of producing oscillations in thepressure applied to the patient during insufflation, exsufflation andpause times;

FIG. 26 is a graph showing examples of pressure, flow and volume graphsthat are viewable on the GUI of the respiratory devices of FIGS. 1-21based on measurements taken by one or more sensors of the device;

FIG. 27 is graph showing an example of a spirometry curve of volumetricflow rate v. volume that is viewable on the GUI of the respiratorydevices of FIGS. 1-21;

FIG. 28 is a diagrammatic view showing the wireless communicationcapability of the respiratory devices of FIGS. 1-21 showing therespiratory device sending and receiving data via communicationinfrastructure to and from one or more remote servers that are coupledto one or more remote computer devices that are configured to analyze orprocess data received from one or more remote respiratory devices'

FIG. 29 is a partial exploded perspective view showing a combinationfastener/hose retention hook arranged for insertion into a hole providedat a back of handle of the housing of the respiratory device of FIG. 1;

FIG. 30 is a partial perspective view, similar to FIG. 29, showing thecombination fastener/hose retention hook attached to the handle of thehousing;

FIG. 31 is a partial perspective view, similar to FIG. 30, showing thehose of the patient interface retained on the combination fastener/hoseretention hook in a storage position;

FIG. 32 is a partial perspective view showing an alternative hoseretention device mounted to a top wall of the housing of the respiratorydevice of FIG. 1 behind the handle;

FIG. 33 is a partial perspective view showing the hose retained on thehose retention device of FIG. 32 in a storage position and showing thehose retention device also being configured to serve as a cord wraparound which a power cord of the respiratory device is able to bewrapped;

FIG. 34 is a partial exploded perspective view of a lower front cornerof the housing of the respiratory devices of FIGS. 1-21 showing a hoseadapter exploded away from a hose port of the respiratory device;

FIG. 35 is a perspective view, similar to FIG. 34, showing the hoseadapter attached to the hose port;

FIG. 36 is a perspective view, similar to FIG. 35, showing a cap of thehose adapter moved to an open position;

FIG. 37 is a perspective view, similar to FIG. 36, showing an end of thehose of the patient interface attached to the hose adapter;

FIG. 38 is a perspective view showing a carrying case configured forcarrying the respiratory devices of FIGS. 1-21, the carrying case havinga door that is opened by pivoting upwardly to provide access to usercontrols on the housing of the respiratory device without the need toremove the respiratory device from the carrying case;

FIG. 39 is a perspective view showing a carrying case configured forcarrying the respiratory devices of FIGS. 1-21, the carrying case beingconfigured for attachment to a wheelchair, and the carrying case havinga door that is opened by pivoting downwardly to provide access to usercontrols on the housing of the respiratory device without the need toremove the respiratory device from the carrying case;

FIG. 40 is a diagrammatic view of the electrical system and pneumaticsystem of the respiratory devices of FIGS. 1-21;

FIG. 41 is an exploded perspective view, similar to FIG. 7, showingcomponents of an alternative embodiment of a respiratory deviceincluding a stepper motor and blower at the left hand side of the pageand showing a rotary valve having a multi-piece manifold with first andsecond stationary plates, separate tubular elements that attach to thestationary plates, a rotary valve member that attaches to a shaft of thestepper motor to rotate and oscillate therewith, a stationary biasingplate that is biased against the rotary valve member by a set of springsthat are situated between the second stationary plate and the biasingplate;

FIG. 42 is an exploded perspective view, similar to FIGS. 7 and 41,showing components of another alternative embodiment respiratory deviceincluding a stepper motor at the left hand side of the page, a blower atthe right hand side of the page, and a valve and manifold assemblysituated therebetween and having first and second molded manifoldportions, first and second stationary plates and a bow-tie shaped rotaryvalve member which is sandwiched between the first and second stationaryplates;

FIG. 43 is a front elevation view of the bow-tie shaped rotary valvemember of FIG. 42;

FIG. 44 is a front elevation view showing the bow-tie shaped rotaryvalve member of FIG. 43 located adjacent the first stationary platewhich is installed into the first manifold portion, the bow-tie shapedrotary valve member being oriented in a first position in which firstand second flow passages are not blocked by wing portions of the bow-tieshaped rotary valve member;

FIG. 45 is a view, similar to FIG. 44, showing the bow-tie shaped rotaryvalve member rotated to a second position having the wing portionsblocking the first and second passages such that third and fourth flowpassages are not blocked by the wing portions;

FIG. 46 is a view, similar to FIGS. 44 and 45, showing the bow-tieshaped rotary valve member rotated to a third position partiallyblocking the first, second, third, and forth passages;

FIG. 47 is a perspective view showing the blower, stepper motor andmanifold assembly of FIG. 72 installed within a housing of theassociated respiratory device;

FIG. 48 is a perspective view of a handset that is coupleable to thetube of the patient interface of FIG. 1 in lieu of, or in addition to,the mask;

FIG. 49 is a cross sectional view of the handset of FIG. 48 taken alongthe long dimension of the handset;

FIG. 50 is a cross sectional view of the handset of FIG. 48 taken alonga lateral dimension of the handset through a threaded plug that isreceived in a nebulizer port of the handset in the absence of anebulizer;

FIG. 51 is a perspective view of an end of the handset showing anadjustable ring exploded away from the end of the handset to expose anoblong aperture at a top of the handset adjacent the end. adetent-receiving depression at a side of the handset adjacent the end,and an annular retention groove adjacent the end, the adjustable ringhaving a large finger tab projecting from an offset channel portion ofthe ring, the ring being oriented in a first position with the channelportion aligned with the oblong aperture;

FIG. 52 is a perspective view, similar to FIG. 51 but at a differentviewing angle, showing a flexible finger of the ring having a detentprojecting radially inwardly therefrom and showing the ring oriented ina second position with the channel member misaligned with the aperture,the ring having projections that project radially inwardly from the ringand that are received in the retaining groove when the ring is assembledonto the end of the handset;

FIG. 53 is a diagrammatic view showing a filter unit coupled to arespiratory device and to a hose and having an oxygen inlet tube and anoxygen measurement tube coupled to respective inlet and outlet tubes ofthe filter unit on opposite sides of a filter;

FIG. 54 is an exploded view showing a filter unit arranged for couplingto a patient port of a respiratory device, the filter unit having a setof prongs that enter into apertures spaced about a main tube of theport;

FIG. 55 is a cross sectional view of the filter unit and patient portshowing the filter unit coupled to the port so that the prongs extendthrough the apertures to engage switches, various embodiments of thefilter unit have a different number of prongs (e.g., one, two, three,etc.) which indicate the type of filter unit or patient interface beingused with the respiratory device;

FIG. 56 is a screen shot of a home screen of a respiratory device, thehome screen including icons or buttons that are selected to determinewhether the respiratory device operates in a positive pressure therapymode or in and insufflation/exsufflation therapy mode;

FIG. 57 is a screen shot of a positive pressure therapy screen thatresults if the positive pressure therapy mode button is selected on thehome screen;

FIG. 58 is a presets screen that permits a user to select from a numberof preset therapies that are stored in the respiratory device and thatare listed on a selection menu;

FIG. 59 is a screen shot of an insufflation/exsufflation therapy screenthat results if the insufflation/exsufflation therapy mode button isselected on the home screen;

FIG. 60 an example of a first automatic insufflation/exsufflation modetherapy screen that results if an automatic mode button or icon of thescreen of FIG. 59 is selected or if a preset therapy selected on thescreen of FIG. 58 is a stored automatic insufflation/exsufflationtherapy;

FIG. 61 is an example of a second automatic insufflation/exsufflationmode therapy screen showing various information about the status andprogress of the automatic insufflation/exsufflation therapy as itoccurs;

FIG. 62 an example of a first manual insufflation/exsufflation modetherapy screen that results if a manual mode button or icon of thescreen of FIG. 59 is selected or if a preset therapy selected on thescreen of FIG. 58 is a stored manual insufflation/exsufflation therapy;

FIG. 63 is an example of a second manual insufflation/exsufflation modetherapy screen showing various information about the status and progressof the manual insufflation/exsufflation therapy as it occurs;

FIG. 64 an example of a first automatic positive pressure therapy modescreen that results if an automatic mode button or icon of the screen ofFIG. 57 is selected or if a preset therapy selected on the screen ofFIG. 58 is a stored automatic positive pressure therapy;

FIG. 65 is an example of a second automatic positive pressure therapymode screen showing various information about the status and progress ofthe automatic positive pressure therapy as it occurs;

FIG. 66 an example of a first manual positive pressure therapy modescreen that results if a manual mode button or icon of the screen ofFIG. 57 is selected or if a preset therapy selected on the screen ofFIG. 58 is a stored manual positive pressure therapy;

FIG. 67 is an example of a second manual positive pressure therapy modescreen showing various information about the status and progress of themanual positive pressure therapy as it occurs;

FIG. 68 is a flow chart of an inspiratory trigger and maskleakage/removal algorithm according to the present disclosure;

FIG. 69 is a graph showing an example of a blower flow characteristiccurve;

FIG. 70 is a graph showing an example of flow characteristics of arespiratory device comparing flow when being delivered to a patient'slungs vs. open flow;

FIG. 71 is a graph showing an example of flow characteristics of arespiratory device comparing flow when the mask of the patient interfaceis removed from a patient vs. open flow;

FIG. 72 is an exploded perspective view, similar to FIGS. 7, 41 and 42,showing components of another alternative embodiment respiratory deviceincluding a stepper motor at the left hand side of the page, a blower atthe right hand side of the page, and a valve and manifold assemblysituated therebetween and having first and second molded manifoldportions, first and second stationary plates and a circular rotary valvemember with surrounding O-ring which is sandwiched between the first andsecond stationary plates;

FIG. 73 is a front perspective view of another respiratory device havinga housing, a patient interface including a hose coupled to the housingat a hose port via filter unit, a graphical user interface (GUI)accessible on a front wall of the housing to control operation of therespiratory device, and a wireless communication module coupled to asidewall of the housing;

FIG. 74 is rear perspective view of the respiratory device of FIG. 73;

FIG. 75 is a front elevation view of the respiratory device of FIG. 73;and

FIG. 76 is a side elevation view of the respiratory device of FIG. 73.

DETAILED DESCRIPTION

A respiratory device 10 includes a housing 12 having a front wall 14 onwhich a graphical user interface 16 is accessible to enter user inputsinto device 10 and to see displayed information regarding the operationof device 10 as shown in FIG. 1. Housing 12 is configured with a handle18 at its top which is gripped by a person to carry device 10. At abottom region of front wall 14 of housing 12, a hose 20 of a patientinterface 22 is attached to a hose port 24 by a hose adapter 26 as willbe discussed in further detail below in connection with FIGS. 34-37. Tothe right of hose port 24 on front wall 14 of housing 12 is an on/offbutton 28 that is pressed sequentially to turn device 10 on and off.Device 10 also has a switch port 30 to which a coupler 32 of a footswitch controller 34 couples, if desired. Foot switch controller 34includes an electrical cable 35 that extends from coupler 32 to a footswitch housing 37 that includes a first switch 37 a and a second switch37 b.

As will be discussed in further detail below, device 10 is operable asan insufflation/exsufflation device or, as such devices are sometimescalled, a cough assist device. Thus, device 10 is capable of applyingpositive pressure and negative pressure to a patient's airway, thepositive pressure being applied during insufflation and the negativepressure being applied during exsufflation. In a manual mode of device10 when foot switch controller 34 is being used, one of switches 37 a,37 b is pressed to signal device 10 to apply the positive insufflationpressure to the patient through the patient interface 22 and the otherof switches 37 a, 37 b is pressed to signal device 10 to apply thenegative insufflation pressure to the patient through the patientinterface 22. If neither of switches 37 a, 37 b is pressed, then a restor pause pressure is applied to the patient's airway. If foot switchcontroller 34 is not being used, then user inputs on GUI 16 are selectedduring the manual mode of device 10 to switch between insufflation,exsufflation, and pause pressures. In some embodiments, device 10 isoperable to provide other modes of respiratory therapy such ascontinuous positive expiratory pressure (CPEP) and continuous highfrequency oscillation (CHFO), just to name a couple. CPEP and CHFO aresometimes referred to herein, collectively, as Intrapulmonary PercussiveVentilation (IPV).

In the illustrative example, patient interface 22 includes a mask 36which is configured to engage a patient's face and generally seal thearea around the patient's nose and mouth. In other embodiments, patientinterface 22 includes a mouthpiece (not shown, but well-known in theart) rather than the illustrative mask 36 and the mouthpiece has an endportion that a patient places inside his or her mouth. Patient interface22 includes a first tubular segment 38 extending from mask 36, a filterunit 40 coupled to tubular segment 38, and a tubular Y-connector 42 thatinterconnects filter unit 40 and hose 20. Filter unit 40 includes afilter (not shown) to filter the air and/or breathing gas being inspiredand expired while the patient is wearing mask 36 during the operation ofdevice 10.

Tubular Y-connector 42 has a first portion 42 a that connects to filterunit 40, a second portion 42 b that connects to an end of hose 20, and athird portion 42 c that connects to a nebulizer 44. Use of nebulizer 44with device 10 is optional and so, in those embodiments in whichnebulizer 44 is omitted, tubular Y-connector 42 is not needed and isreplaced by a tubular segment (not shown) that is similar to tubularsegment 38. However, in the illustrative example, nebulizer 44 is avibrating screen or vibrating plate nebulizer and so an electrical cable46 extends from nebulizer 44 and terminates at an electrical connector48 which is configured for coupling to an electrical nebulizer port 50located at the lower region of front face 14 of housing 12 of device 10between button 28 and port 30.

Nebulizer 44 includes a cap 52 which is opened from its illustrativeclosed position so that a nebulizer container (not shown) that containsa liquid substance or medicament is able to be attached to the nebulizer44. When connector 48 is coupled to port 50 of device 10, an electricalsignal is applied to nebulizer 44 to vibrate the screen or plate,thereby to nebulize the liquid substance contained in the nebulizercontainer. The nebulized substance flows from the nebulizer 44 andbecomes entrained in the pressurized gas being provided to the patientby device 10 through the patient interface 22.

Still referring to FIG. 1, housing 12 includes a molded front housingshell 54 and a molded rear housing shell 56 that couple together to formthe overall structure of housing 12. Front housing shell 54 includesfront wall 14 and a sidewall 58 that is integrally formed with frontwall 14. In the illustrative example, sidewall 58 of device 10 has aUniversal Serial Bus (USB) port 60 to which other devices (e.g., tabletcomputers, laptop computers, memory sticks, printers, personalcomputers, etc.) with mating USB couplers can couple, as desired asindicated diagrammatically in FIG. 40. Sidewall 58 also has a pulseoximeter port 62 for coupling to a pulse oximeter (not shown) and a port(not shown in FIG. 1) to which a wireless communication module 64couples. In some embodiments, module 64 communicates wirelesslyaccording to the Bluetooth protocol, but all types of wirelesscommunication are intended to be within the scope of the presentdisclosure.

Referring to FIGS. 2-5, front, rear, side and top views, respectively,of device 10 are shown. However, the device 10 of FIGS. 2-5 does notinclude port 50 and so the device 10 of FIGS. 2-5 is an example in whichnebulizer 44 is not used. Otherwise, device 10 of FIGS. 2-5 is just likedevice 10 of FIG. 1 and so like reference numerals are used to denotelike components. Dimensional information is included in FIGS. 3-5 forthe illustrative device 10. Thus, the height of device 10 from itsbottom 65 to a top of handle 18 is 297 millimeters (mm) as indicated inFIG. 3. The thickness from a front of handle to a back of handle 18 is42 mm and a height of device 10 from its bottom to a top wall 66 of arear portion of rear housing shell 56 is 218 mm as indicated in FIG. 4.A depth of device 10 from front to back is 192 mm and a width of device10 from side to side is 270 mm as indicated in FIG. 5. Rear housingshell 56 of device 10 has a back wall 68 that includes a grill 70 with aplurality of openings to permit ambient air or atmosphere to flow intoan interior region of housing 12 and to permit air in the interiorregion to flow out of housing 12 to atmosphere during the operation ofdevice 10.

Referring to FIG. 40, a diagrammatic view of the electrical system 72and the pneumatic system 74 of device 10 is provided. Electrical system72 includes control circuitry 76 which, in turn, includes amicroprocessor 78 and memory 80. In some embodiments, microprocessor 78and memory 80 are part of a single microcontroller integrated circuitchip. As shown in FIG. 40, GUI 16, on/off button 28, foot switch unit34, nebulizer 44, SpO2 port 62, USB port 60, and wireless communicationmodule 64 are coupled electrically to control circuitry 76. A wirelesscommunication module port 82 is shown diagrammatically and provides thecommunication link between module 64 and circuitry 76.

An alternating current (AC) power cord 84 is also coupled to circuitry76. Circuitry 76, therefore, includes components to convert the incomingAC power to the proper voltage levels, e.g., 5 Volts (V), 12 V, 24 V,etc., required by various components of systems 72, 74. In someembodiments, device 10 includes a lithium ion battery pack which ischarged while power cord 84 is plugged into a power outlet. In some suchembodiments, the components of device 10 are powered from the lithiumion battery pack regardless of whether cord 84 is plugged into a poweroutlet. Battery packs or batteries that operate according totechnologies other than lithium ion technology are also within the scopeof this disclosure for use in device 10.

It should be appreciated that although circuitry 76 is showndiagrammatically as a single block in FIG. 40, it is within the scope ofthis disclosure for circuitry 76 to include electrical components thatare provided on multiple, separate circuit boards which areinterconnected via suitable conductors. It is also within the scope ofthis disclosure for circuitry 76 to comprise a single circuit board withthe associated electrical components mounted thereon. Of course, somecomponents of electrical system 72 may not be attached to any circuitboard at all. For example, button 28 and ports 60, 62, 82 may bephysically mounted to housing 12 rather than to a circuit board.Ultimately, however, suitable conductors connect these components tocontrol circuitry 76.

In FIG. 40, the double headed arrows leading between circuitry 76 andthe various other components are intended to imply that bidirectional ortwo-way communication occurs between circuitry 76 and the associatedcomponents. However, this is not to exclude the possibility that otherembodiments of device 10 may have one-way communication betweencircuitry 76 and one or more of the other elements. Similarly, theone-way arrows from port 62 and power cord 84 is not intended to excludethe possibility of two-way communication between circuitry 76 and thesecomponents in other embodiments. For example, data over power linecommunication technology may be employed, if desired, to transmitsignals from circuitry 76 over AC power cord 84 away from device 10.

Still referring to FIG. 40, pneumatic system 74 includes a blower 86 anda combination direction/oscillation valve 88 pneumatically coupled to aninlet 90 and an outlet 92 of blower 86 via respective conduits 94, 96.System 74 includes a stepper motor 98 which controls movement of a valvemember of valve 88 as will be discussed below in connection with arotary plate valve embodiment shown in FIGS. 6-16 and in connection witha rotary spool valve embodiment shown in FIGS. 17-21. System 74 includesa conduit 100 that couples valve 88 to patient interface 22 and aconduit 102 that couples valve 88 to atmosphere 104.

One or more sensors 106 are placed in pneumatic communication withconduit 100 and are in electrical communication with control circuitry76 via conductors 108. Thus, one could allocate sensor(s) 106 as being acomponent of either electrical system 72 or pneumatic system 74 or both.Sensor(s) 106 include a pressure sensor or a flow sensor or both.Suitable electrical conductors 110, 112 also interconnect blower 86 andstepper motor 98, respectively, to circuitry 76. In general, conductors110, 112 communicate control signals from circuitry 76 to blower 86 andstepper motor 98 and communicate feedback signals from blower 86 andstepper motor 98 to circuitry 76. Examples of feedback signals fromblower 86 include rotational speed of an impeller of the blower 86 andtemperature of the blower 86. The control signal to the blower 86 mayinclude, for example, a voltage signal such as a pulse width modulated(PWM) signal. Examples of feedback signals from stepper motor 98 includea step count number indicative of a position of an output shaft of themotor 98 and a temperature of the motor 98. The control signal to thestepper motor 98 may include, for example, a voltage pulse to move themotor output shaft by one step or a series of pulses to move the motoroutput shaft by a corresponding number of steps.

When positive pressure produced at outlet 92 of blower 86 is to besupplied to the patient via patient interface 22, valve 88 is operatedso that pressurized air from blower 86 is communicated from conduit 96through valve 88 to conduit 100 and so that ambient air from atmosphere104 is communicated from conduit 102 through valve 88 to inlet 90 ofblower 86. When negative pressure produced at inlet 90 of blower 86 isto be supplied to the patient interface 22, valve 88 is operated so thatsuction from blower 86 is communicated from conduit 94 through valve 88to conduit 100 and so that pressurized air from blower 86 iscommunicated from conduit 96 through valve 88 to atmosphere 104 viaconduit 102.

FIG. 40 has one-way arrows in conduits 94, 96 to indicate a direction offlow of air to or from inlet 90 and outlet 92 of blower 86,respectively, whereas bidirectional arrows are shown in conduits 100,102 to indicate that air is sometimes flowing from valve 88 towardpatient interface 22 or atmosphere 104 and that air is sometimes flowingfrom valve away from patient interface 22 or atmosphere 104. When air isflowing from valve 88 toward patient interface 22 to provide positivepressure to a person's airway, air is flowing toward valve 88 fromatmosphere 104. Conversely, when air is flowing toward valve 88 frompatient interface 22 to provide negative pressure to a person's airway,air is flowing away from valve 88 toward atmosphere 104. To state itanother way, valve 88 is operable to switch between a positive pressureposition in which air is drawn from atmosphere 104 to be pressurized byblower 86 for delivery to the patient via patient interface 22 and anegative pressure position in which air is drawn from the patient viapatient interface 22 and is blown to atmosphere 104 by blower 86.

According to this disclosure, valve 88 is also operable while in thepositive pressure position and/or the negative pressure position toproduce oscillations in the pressure being delivered to patientinterface 22. It is contemplated by this disclosure that, in someembodiments, only one stepper motor 98 is used in device 10 to controlwhether valve 88 is in the positive pressure position or the negativepressure position and to control whether the valve 88 producesoscillations while in either of these positions. Using only one steppermotor 98 in device 10 is an improvement from a cost, size and weightstandpoint over known prior art devices that use multiple stepper motorsor components in addition to a direction valve to produce oscillatorypressure.

Referring now to FIGS. 6-9, the rotary plate valve embodiment of valve88 includes a first stationary plate 114 attached to a first manifoldblock 116, a second stationary plate 118 attached to a second manifoldblock 120, and a rotatable plate 122 that is sandwiched between thefirst and second stationary plates 114, 118. Plates 114, 118, 122 arecircular or round in shape with plates 114, 118 having substantiallyequivalent diameters and plate 122 having a diameter less than that ofplates 114, 118. Valve 88 further includes an annular shim 124 thatsurrounds the outer periphery of plate 122 and serves as a spacerbetween plates 114, 118 to provide a space that accommodates rotatableplate 122. In this regard, shim 124 is round or circular having an outerperiphery that is substantially equivalent to the outer peripheries ofplates 114, 118 and having a large central bore 126, shown in FIG. 7,that is sized to receive plate 122 therein within only a minimal amountof clearance therebetween as shown in FIGS. 8 and 9.

Plate 114 has four holes 128 a, 128 b, 128 c, 128 d and plate 118 hasfour holes 130 a, 130 b, 130 c, 130 d as shown best in FIG. 7. Plate 114has a central hole 132 and plate 118 has a central hole 134. Holes 128a, 128 b, 128 c, 128 d of plate 114 align with respective holes 130 a,130 b, 130 c, 130 d of plate 118. In the illustrative example, holes 128a-d, 130 a-d, 132, 134 are each round. Furthermore, each hole 128 a-dand each hole 130 a-d is spaced circumferentially by 90° from each ofthe next two adjacent holes 128 a-d, 130 a-d of respective plates 114,118 when measured from center-to-center of each hole 128 a-d, 130 a-d.The diameter of each hole 128 a-d, 130 a-d is substantially equivalentto each of the other holes 128 a-d, 130 a-d and is about 25% or less ofthe diameter of the respective plate 114, 118.

Plate 122 has four holes 136 a, 136 b, 136 c, 136 d as shown best inFIG. 7. Holes 136 a-d are the same size and shape as holes 128 a-d, 130d but are grouped into two pairs that are closer togethercircumferentially than 90°. In particular, holes 136 a, 136 d are afirst pair and holes 136 b, 136 c are a second pair. Holes 136 a, 136are spaced apart from each other circumferentially by about 45° andholes 136 b, 136 c are spaced apart from each other circumferentially byabout 45° when measured center-to-center. Plate 122 has a cross-shapedcentral hole 138 that receives a cross-shaped hub 140 shown in FIG. 7.Hub 140 has a central hole 142 therethrough which receives a valve shaft144. Shaft 144 mounts to an output shaft 146 of stepper motor 98 with acoupler 148. A set of fasteners 99 such as bolts, screws, or dowel pins,extend through apertures in a flange 101 of stepper motor 98 and arereceived in holes 103 of manifold block 120 to mount stepper motor 98 toblock 120. With reference to FIGS. 6 and 7, a set of fasteners 105extend through holes 107 provided in blocks 116, 118, plates 114, 118,and shim 124 to couple these elements together.

Coupler 148 includes, or serves as, a bushing or bearing for shafts 144,146 and is received in a bore 150 formed in a central region of manifoldblock 120. An end of shaft 144 opposite from coupler 148 is received ina bore 152 of a bushing or bearing 154 which, in turn, is received inbore 156 formed in manifold block 116. Thus, shaft 144 extends throughbore 150 of manifold block 120, hole 134 of plate 118, hole 142 of hub140 (as well as hole 138 of plate 122), hole 132 of plate 114 and bore156 of manifold block 116. Hub 140 is press fit onto shaft 144, or isotherwise keyed to shaft 144, so that rotational motion imparted toshaft 144 by output shaft 146 of stepper motor 98 is transferred torotatable plate 122.

Manifold block 116 includes a series of passageways that cooperate toform the conduits 94, 96 discussed above in connection with FIG. 40.Manifold block 120 includes a series of passageways that cooperate toform the conduits 100, 102 discussed above in connection with FIG. 40.In particular, manifold block 116 includes passageways 158 a, 158 b, 158c, 158 d, shown in FIG. 7, that correspond to passageway 96 of FIG. 40which receives pressurized air from blower outlet 92. In theillustrative example, outlet 92 is formed as an elbow fitting attachedto an end of an outlet conduit 160 of blower 86. Outlet 92 pneumaticallycouples to passageway 158 a so that pressurized air is communicated fromblower 86 through passageways 158 a, 158 b to passageways 158 c, 158 d.An outlet of passageway 158 c is pneumatically coupled to hole 128 b ofplate 114 and is aligned with hole 130 b of plate 118. An outlet ofpassageway 158 d is pneumatically coupled to hole 128 a of plate 114 andis aligned with hole 130 a of plate 118.

Manifold block 116 also includes passageways 162 a, 162 b, 162 c shownin FIG. 7, that correspond to passageway 94 of FIG. 40 which receivessuction from blower inlet 90. In the illustrative example, inlet 90 ofblower 86 is formed as a small tubular segment that pneumaticallycouples to an outlet of passageway 162 a. Suction produced at outlet 90of blower pneumatically couples to passageway 162 a so that suction(i.e., negative pressure) is communicated from blower 86 throughpassageway 162 a to passageways 162 b, 162 c. An inlet of passageway 162a is pneumatically coupled to hole 128 d of plate 114 and is alignedwith hole 130 d of plate 118. An inlet of passageway 162 c ispneumatically coupled to hole 128 c of plate 114 and is aligned withhole 130 c of plate 118.

Blower 86 is attached to a plate 164 with suitable fasteners 166 such asbolts, screws, or dowel pins. A motor 168 of blower 86 extends through ahole 170 in plate 164. A set of standoffs 172 keep plate 164 at a properdistance from manifold block 116 to accommodate blower 86. As shown inFIG. 7, a set of fasteners 174 extend from standoffs 172 and arereceived by holes 176 formed in manifold block 116 (only two holes 176can be seen in FIG. 7). Thus, blower 86 is sandwiched between plate 164and manifold block 116, although motor 168 of blower 86 projects throughhole 170 of plate 164 as mentioned above.

Manifold block 120 includes a series of passageways 178 a, 178 b, 178 c,shown in FIG. 7, that correspond to conduit 100 of FIG. 40 whichreceives either positive pressure or negative pressure from blower 86.An opening 180 of passageway 178 a is coupled to the patient interface22. An inlet of passageway 178 b is pneumatically coupled to hole 130 bof plate 118 and is aligned with hole 128 b of plate 114 and with theoutlet of passageway 158 c of manifold block 116. An outlet ofpassageway 178 c is pneumatically coupled to hole 130 c of plate 118 andis aligned with hole 128 c of plate 114 and with the inlet of passageway162 c of manifold block 116.

Manifold 120 also includes a first passageway 182 a, 182 b and a secondpassageway 184 a, 184 b that, together, correspond to conduit 102 ofFIG. 40. First passageway 182 a, 182 b serves an air intake fromatmosphere and second passageway 184 a, 184 b serves as an exhaust toatmosphere. An outlet of passageway 182 b is pneumatically coupled tohole 130 d of plate 118 and is aligned with hole 128 d of plate 114 andwith an inlet of passageway 162 a of manifold block 116. An inlet ofpassageway 184 b is pneumatically coupled to hole 130 a of plate 118 andis aligned with hole 128 a of plate 114 and with an outlet of passageway158 d of manifold block 116.

Depending upon the position of plate 122 relative to plates 114, 118some of holes 128 a-d, holes 130 a-d, and 136 a-d are aligned to providepneumatic communication between corresponding passageways 158 c, 158 d,162 a, 162 c of block 116 and passageways 178 b, 178 c, 182 b, 184 b ofblock 120 and others of holes 128 a-d, holes 130 a-d, and 136 a-d areblocked to prevent pneumatic communication between correspondingpassageways 158 c, 158 d, 162 a, 162 c of block 116 and passageways 178b, 178 c, 182 b, 184 b of block 120. For example, in FIG. 8, rotatableplate 122 is in a first position during application of positive pressureto patient interface 22 through opening 180 of manifold block 120 and,in FIG. 9, rotatable plate 122 is in a second position duringapplication of suction or negative pressure to patient interface 22through opening 180 of manifold block 120. When moving between the firstand second positions, plate 122 rotates through a first angulardisplacement of less than 45°, such as about 22.5°.

With reference to FIG. 8, when plate 122 is in the first position andblower 86 is operated, atmospheric air is drawn into passageway 182 a ofblock 120 as indicated by arrow 186 and then is drawn through passageway182 b, hole 130 d of plate 118, hole 136 d of plate 122, hole 128 d ofplate 114 and into passageway 162 a of block 116 as indicated by arrow188. The air in passageway 162 a is drawn into blower 86 through inlet90 and is pressurized by an impeller (not shown) of blower 86. Thepressurized air is forced by blower 86 through outlet 92 and, in turn,is forced through passageways 158 a, 158 c, hole 128 b of plate 114,hole 136 b of plate 122, hole 130 b of plate 118 and into passageway 178b as indicated by arrow 190. The air in passageway 178 b is then forcedthrough passageway 178 a and out of opening 180 to the patient interface22 (not shown in FIG. 8) as indicated by arrow 192. While plate 122 isin the first position, passageways 178 c, 184 b of block 120, holes 130a, 130 c of plate 118, holes 128 a, 128 c of plate 114, and passageways158 d, 162 c of block 116 are closed off or blocked by respective solidportions of plate 122 (e.g., the portions of plate 122 between holes 136a, 136 b and between holes 136 c, 136 d).

With reference to FIG. 9, when plate 122 is in the second position andblower 86 is operated, air from the patient interface 22 is drawn intopassageway 178 a of block 120 through opening 180 as indicated by arrow194 and then is drawn through passageway 178 c, hole 130 c of plate 118,hole 136 c of plate 122, hole 128 c of plate 114 and into passageway 162c of block 116 as indicated by arrow 196. The air in passageway 162 c isdrawn through passageways 162 a, 162 b and into blower 86 through inlet90 and is pressurized by the impeller of blower 86. The pressurized airis forced by blower 86 through outlet 92 and, in turn, is forced throughpassageways 158 a-c, hole 128 a of plate 114, hole 136 a of plate 122,hole 130 a of plate 118 and into passageway 184 b as indicated by arrow198. The air in passageway 184 b is then forced through passageway 184 aand out of an opening 200 to the atmosphere as indicated by arrow 202.While plate 122 is in the second position, passageways 178 b, 182 b ofblock 120, holes 130 b, 130 d of plate 118, holes 128 b, 128 d of plate114, and passageways 158 c, 162 a of block 116 are closed off or blockedby respective solid portions of plate 122 (e.g., the portions of plate122 between holes 136 a, 136 b and between holes 136 c, 136 d).

An example of a suitable blower 86 for use in device 10 is the model no.U85MX-024KX-4 blower available from Micronel AG of Tagelswangen,Switzerland. Examples of a suitable stepper motor 98 for use in device10 include the model no. STM17Q-3AE stepper motor available from AppliedMotion Products, Inc. of Watsonville, Calif., U.S.A. and the model no.4209S-07PD-01RO stepper motor available from LIN Engineering of MorganHill, Calif., U.S.A.

As shown in FIGS. 10-12, when plate 122 is in the first position, plate122 can be oscillated back and forth in the directions of first andsecond arrows 204, 206 through a second angular displacement that isless than the first angular displacement mentioned above. The secondangular displacement corresponds to the amount of movement of plate 122in direction 204 from the maximum pressure position of FIG. 10, thoughan intermediate position of FIG. 11, to a minimum pressure position ofFIG. 12. The second angular displacement also corresponds to the amountof movement of plate 122 in direction 206 from the minimum pressureposition of FIG. 12 back to the maximum pressure position of FIG. 10.

In the illustrative example, the second angular displacement is about10°. Stepper motor 98 is operable so that the frequency of oscillationof plate 122 is within the range of about 1 Hertz (Hz) to about 20 Hz,as selected by a user on GUI 16. As viewed in FIGS. 10-12, plate 122rotates in a clockwise direction 204 from the maximum pressure positionof FIG. 10 to the intermediate position of FIG. 11 and then to theminimum pressure position of FIG. 12. From the minimum pressure positionof FIG. 12, plate 122 rotates in counterclockwise direction 206 to theintermediate position of FIG. 11 and then back to the maximum pressureposition of FIG. 10.

In FIGS. 10-12, the dashed circles are labeled with the referencenumbers corresponding to the holes of plates 114, 118, 122 and the holesof each plate 114, 118, 122 are depicted diagrammatically as havingdifferent sizes or diameters. However, it should be appreciated that theholes of each respective plate 114, 118, 122 are substantially equal insize or diameter in the illustrative embodiment. Furthermore, thestippling in FIGS. 10-12 indicates the amount of space available forpressurized air to pass through the rotary plate valve 88. Finally, adot is superimposed on the pressure graphs that are located in FIGS.10-12 beneath the respective diagrammatic valve 88 depictions.

The dot in FIG. 10 is at a top of a positive pressure sinusoidal tracebecause plate 122 is at the maximum pressure position having holes 128d, 130 d, 136 d aligned with each other and having holes 128 b, 130 b,136 b aligned with each other. The dot in FIG. 11 is at a hypotheticalpositive baseline pressure corresponding to the intermediate position ofplate 122 having hole 136 d misaligned by a relatively small amountrelative to holes 128 d, 130 d and having hole 136 b misaligned by arelatively small amount relative to holes 128 b, 130 b. The dot in FIG.12 is at the bottom of the positive pressure sinusoidal trace becauseplate 122 is at the minimum pressure position having hole 136 dmisaligned by a relatively large amount relative to holes 128 d, 130 dand having hole 136 b misaligned by a relatively large amount relativeto holes 128 b, 130 b.

When plate 122 is in the minimum pressure position of FIG. 12, a pair ofsmall passages is created by holes 136 a, 136 c with respective holes128 a, 130 a and 128 c, 130 c. At the patient interface 22, the air flowthrough these small passages contributes to the reduction in airflowthrough the larger passages formed by holes 128 b, 130 b, 136 b andholes 128 d, 130 d, 136 d. Thus, the pair of small passages of holes 128a, 130 a, 136 a and holes 128 c, 130 c, 136 c has an effect tocontribute to the reduction in positive pressure output to the patientinterface 22.

As shown in FIGS. 13-15, when plate 122 is in the second position, plate122 can also be oscillated back and forth in the directions of first andsecond arrows 204, 206 through the second angular displacement mentionedabove. In FIGS. 13-15, the second angular displacement corresponds tothe amount of movement of plate 122 in direction 206 from the maximumpressure position of FIG. 13, though an intermediate position of FIG.14, to a minimum pressure position of FIG. 15. The second angulardisplacement of FIGS. 13-15 also corresponds to the amount of movementof plate 122 in direction 204 from the minimum pressure position of FIG.15 back to the maximum pressure position of FIG. 13.

In the illustrative example, the second angular displacement is about10° regardless of whether plate 122 is in the first or second position.Furthermore, stepper motor 98 is operable so that the frequency ofoscillation of plate 122 is within the range of about 1 Hertz (Hz) toabout 20 Hz, as selected by a user on GUI 16, regardless of whetherplate 122 is in the first or second position. As viewed in FIGS. 13-15,plate 122 rotates in counterclockwise direction 206 from the maximumpressure position of FIG. 13 to the intermediate position of FIG. 14 andthen to the minimum pressure position of FIG. 15. From the minimumpressure position of FIG. 15, plate 122 rotates in clockwise direction204 to the intermediate position of FIG. 14 and then back to the maximumpressure position of FIG. 13.

As was the case with FIGS. 10-12, in FIGS. 13-15, the dashed circles arelabeled with the reference numbers corresponding to the holes of plates114, 118, 122 and the holes of each plate 114, 118, 122 are depicteddiagrammatically as having different sizes or diameters. As was also thecase with FIGS. 10-12, the stippling in FIGS. 13-15 indicates the amountof space available for pressurized air to pass through the rotary platevalve 88. Finally, a dot is superimposed on the pressure graphs that arelocated in FIGS. 13-15 beneath the respective diagrammatic valve 88depictions.

The dot in FIG. 13 is at a bottom of a negative pressure sinusoidaltrace because plate 122 is at the maximum pressure position having holes128 a, 130 a, 136 a aligned with each other and having holes 128 c, 130c, 136 c aligned with each other. The dot in FIG. 14 is at ahypothetical negative baseline pressure corresponding to theintermediate position of plate 122 having hole 136 a misaligned by arelatively small amount relative to holes 128 a, 130 a and having hole136 c misaligned by a relatively small amount relative to holes 128 c,130 c. The dot in FIG. 15 is at the top of the negative pressuresinusoidal trace because plate 122 is at the minimum pressure positionhaving hole 136 a misaligned by a relatively large amount relative toholes 128 a, 130 a and having hole 136 c misaligned by a relativelylarge amount relative to holes 128 c, 130 c.

When plate 122 is in the minimum pressure position of FIG. 15, a pair ofsmall passages is created by holes 136 b, 136 d with respective holes128 b, 130 b and 128 d, 130 d. At the patient interface 22, the air flowthrough these small passages slightly counteracts the airflow throughthe larger passages formed by holes 128 a, 130 a, 136 a and holes 128 c,130 c, 136 c. However, the pair of small passages of holes 128 b, 130 b,136 b and holes 128 d, 130 d, 136 d has only a negligible effect on thenegative pressure applied to the patient interface 22.

According to this disclosure, valve 88 is controllable to generate apause or rest pressure at the patient interface 22. While the pausepressure is programmable by a user to be set at any pressure, positiveor negative, that respiratory device 10 is capable of generating, thepause pressure is typically a positive pressure that is less than theinsufflation pressure. The graphs in FIGS. 10-15 each show a positivepause pressure to the right of the negative exsufflation pressure inaccordance with a typical scenario.

Referring now to FIG. 16, if the rest pressure is set to zero pressure(i.e., neither above nor below atmospheric pressure), then rotatableplate 122 is moved to a position in which a substantially equivalentamount of positive pressure and negative pressure is applied to patientinterface 22. Thus, when plate 122 is in the position shown in FIG. 16relative to plates 114, 118, the air flow passages through valve 88formed by hole 136 a with holes 128 a, 130 a, formed by hole 136 b withholes 128 b, 130 b, formed by hole 136 c with holes 128 c, 130 c, andformed by hole 136 d with holes 128 d, 130 d are substantiallyequivalent in size. As indicated by double headed arrow 204, 206 in FIG.16, plate 122 is also able to be cyclically oscillated back and forth inopposite directions to create oscillations in the rest or pausepressure. Such oscillations in the rest pressure are shown in the graphsof FIGS. 10-15. It is also possible for plate 122 to be positioned tocreate a rest pressure that has a positive baseline pressure or anegative baseline pressure, as desired, based on user inputs on GUI 16.

Referring now to FIGS. 17-21, a rotary spool valve embodiment of valve88 includes a stationary cylinder 208 that is retained between a firstmanifold block 210 and a second manifold block 212. The rotary spoolvalve 88 includes a rotatable cylinder or spool 214, shown best in FIG.18, which is received in the bore of stationary cylinder 208. Rotarymotion of output shaft 146 of stepper motor 98 is transferred to spool214 through a rotatable hub 216, a cross-shaped member 218 having a bore219 that receives a complimentary shaped lug 220 of hub 216, and a plug222 having a cross-shaped hole (not shown) that receives thecross-shaped member 218. Plug 222 threads into the bore of spool 214 atthe end of spool 214 nearest stepper motor 98.

A circular plate 224 attaches to manifold blocks 210, 212 by use of fourfasteners 226, such as bolts, screws, or dowel pins, that extend throughapertures 227 provided near the periphery of plate 224 and are receivedin holes 228 provided in manifold blocks 210, 212 as shown in FIGS. 17and 18. Plate 224 has a circular hub 230 at its center that is situatedadjacent rotatable hub 216. Plate 224 also has an additional set ofapertures 232 that receive fasteners (not shown) which thread or pressfit into apertures 234 of stepper motor 98 to mount stepper motor 98 toplate 224. A small hole 236 extends through the center of plate 224 andhub 230. Output shaft 146 of stepper motor extends through hole 236 andis received in a hole 238 provided in rotatable hub 216. Hub 216 ispress fit onto shaft 146 or is otherwise keyed to shaft 146 to rotatetherewith.

In addition to fasteners 226 that interconnect plate 224 with manifoldblocks 210, 212, fasteners 240 such as bolts or screws, and dowel pins242 are provided to connect manifold blocks 210, 212 together. As shownin FIGS. 17 and 18, fasteners 240 and dowel pins 242 are orientedvertically whereas fasteners 226 are oriented horizontally. Manifoldblocks 210, 212 have holes 244, 245, respectively, that receivefasteners 240 and holes 246, 247 that receive dowel pins 242.

Blower 86 is attached to a plate 248 with suitable fasteners 250 such asbolts, screws, or dowel pins. Motor 168 of blower 86 extends through ahole 252 in plate 248. A set of standoffs 254 keep plate 248 elevated ata proper distance from at top of manifold block 210 to accommodateblower 86. As shown in FIGS. 17 and 18, a set of fasteners 256 extendthrough standoffs 254 and are received by holes 258 formed in manifoldblock 210 (only three holes 258 can be seen in FIG. 18). Thus, blower 86is sandwiched between plate 248 and manifold block 210, although motor168 of blower 86 projects through hole 252 of plate 248 as shown inFIGS. 17 and 18. One or more washers 260 may be used, as desired, tofine tune the spacing between the top surface of manifold block 210 andplate 248. Washers 260 are positioned on the lower ends of fasteners 256beneath standoffs 254 and atop manifold block 210.

Manifold blocks 210, 212 each have a set of arch-shaped partition walls262 as shown best in FIGS. 19-21. Stationary cylinder 208 is capturedbetween partition walls 262 with each partition wall 262 of manifoldblock 210 being substantially vertically aligned with a respectivepartition wall 262 of manifold block 212. In some embodiments, annularrings or gaskets 264 are provided around stationary cylinder 208 atspaced locations corresponding to the locations of respective partitionwalls 262 as shown, for example, in FIGS. 17 and 18. Thus, thearch-shaped edges of partition walls 262 clamp against the rings 264 toenhance the pneumatic sealing between walls 262 and cylinder 208. Thewalls 262 cooperate to form a set of pockets 266 a, 266 b, 266 c, 266 d,266 e, although end walls 268, 270 of manifold blocks 210, 212,respectively, provide one of the boundaries for pocket 266 e. Also, openends of cylinder 208 and spool 214 are situated in pocket 266 e. Theopposite end of cylinder 208 and spool 214 are closed off by plug 222.

In the embodiment of FIGS. 17 and 18, blower 86 is located on manifoldblock 210 so that inlet 90 of blower 86 is in pneumatic communicationwith pocket 266 a through a hole 268 formed in the top of manifold block210 above pocket 266 a. Outlet 92 of blower is in pneumaticcommunication with pocket 266 e through a hole 270 formed in the top ofmanifold block 210 above pocket 266 e. A conduit (not shown) extendsfrom outlet 92 of blower 86 to hole 270. In the embodiment of FIGS.19-21, the situation is reversed in that the inlet 90 of blower 86 is inpneumatic communication with pocket 266 e and outlet 92 of blower 86 isin pneumatic communication with pocket 266 a via a conduit 272. Thus,the rotary spool valve 88 according to the present disclosure is able tooperate in an acceptable manner regardless of whether the inlet 90 oroutlet 92 of blower 86 is coupled to pocket 266 a with the other ofinlet 90 or outlet 92 coupled to pocket 266 e.

Stationary cylinder 208 has a set of generally rectangular apertures orholes 274 and spool 214 has a set of generally rectangular apertures orholes 276 as shown best in FIG. 18. A tube 278 of manifold block 212 hasan opening 280 in pneumatic communication with pocket 266 c. Opening 280is also in communication with patient interface 22. Another tube 282 ofmanifold block 212 has an opening (not shown but similar to opening 280)in pneumatic communication with atmosphere. In the embodiment of FIGS.17 and 18, tube 282 communicates pneumatically with pocket 266 b and inthe embodiment of FIGS. 19-21, tube 282 communicates pneumatically withpocket 266 d.

Spool 214 is movable by stepper motor 98 between first and secondpositions relative to cylinder 208. In the first position of spool 214,positive pressure is output from opening 280 to patient interface 22 andin the second position of spool 214, negative pressure is applied topatient interface 22 from opening 280. When spool 214 is in the firstposition, a first subset of holes 276 of spool 214 is aligned with afirst subset of holes 274 of cylinder 208. When spool 214 is in thesecond position, a second subset of holes 276 is aligned with a secondsubset of holes 274 of cylinder 208. Some, but not all, of the holes274, 276 of the first subset are also included in the second subset.

With regard to FIG. 19 in which spool 214 is in the first position, afirst set of arrows 284 is provided to show the flow of air through tube282 into pocket 266 d, then through one of holes 274 and one of holes276 associated with pocket 266 d into the interior region of spool 214where it flows out of the open end of spool 214 into pocket 266 e. Frompocket 266 e, the air is drawn upwardly into the inlet 90 of blower 86to be pressurized by the blower impeller and forced out of the outlet ofblower and tube 272 into pocket 266 a. From pocket 266 a, the air isforced back into the interior region of spool 214 through holes 274, 276associated with pocket 266 a and then the air enters pocket 266 cthrough holes 274, 276 associated with pocket 266 c. The air in pocket266 c is then forced through opening 280 of tube 278 to apply positivepressure to the patient interface 22.

Spool 214 includes an internal wall 286 which can be seen, for example,in FIG. 18 through one of holes 274. The internal wall 286 isapproximately at the midpoint of the length of spool 214. The internalwall 286 blocks pneumatic communication within the interior region ofspool 214 between the blower inlet side and blower outlet side of spool214. So, in FIG. 19 for example, the internal wall 286 prevents thepressurized air entering pocket 266 c from simply flowing all the wayback through spool 214 to pocket 266 e. It can be seen by the routing ofarrows 284 in FIG. 19 that pocket 266 b is bypassed by the air flow.Thus, solid portions of spool 214 block or close off the holes 274 ofcylinder 208 that are associated with pocket 266 b.

With regard to FIG. 20 in which spool 214 is in the second position, asecond set of arrows 288 is provided to show the flow of air from thepatient interface 22 through tube 278 into pocket 266 c, then throughone of holes 274 and one of holes 276 associated with pocket 266 c intothe interior region of spool 214 where it flows out of the open end ofspool 214 into pocket 266 e. From pocket 266 e, the air is drawnupwardly into the inlet 90 of blower 86 to be pressurized by the blowerimpeller and forced out of the outlet of blower and tube 272 into pocket266 a. From pocket 266 a, the air is forced back into the interiorregion of spool 214 through holes 274, 276 associated with pocket 266 aand then the air enters pocket 266 b through holes 274, 276 associatedwith pocket 266 b. The air in pocket 266 c is then forced to atmospherethrough an exhaust opening (not shown) associated with pocket 266 b in abottom of manifold block 212. It can be seen by the routing of arrows288 in FIG. 20 that pocket 266 d is bypassed by the air flow. Thus,solid portions of spool 214 block or close off the holes 274 of cylinder208 that are associated with pocket 266 d.

Referring now to FIG. 21, spool 214 is in an intermediate positionbetween the first and second positions so that a pause or rest pressureis applied to the patient interface 22 via opening 280 of tube 278. Inthe intermediate position, holes 274, 276 associated with pocket 266 con both sides of the internal partition wall 286 of spool 214 arepartially opened. As a result, two air flow arrows 284′, 288′ are shownin FIG. 21 to indicate the air flow. Arrow 288′ represents air beingdrawn into pocket 266 c due to holes 274, 276 on the blower inlet sideof pocket 266 c being opened partially. Air flow 288′ merges withairflow 284′ entering the interior region of spool 214 through tube 282,pocket 266 d, and the holes 274, 276 associated with pocket 266 d. Fromthat point onward, the air flow indicated by arrows 284′ is the same asthat discussed above in connection with arrows 284 and so that portionof the discussion need not be repeated. The fact that arrows 284′ areillustrated as being thicker than arrows 288′ is intended to imply thatthe rest pressure is a positive pressure. However, it is within thescope of this disclosure for spool 214 to be positioned relative tocylinder 208 so as to produce a negative rest pressure or a zero restpressure.

A double headed arrow 290 is shown in FIG. 21 to indicate that spool 214is able to be cyclically oscillated back and forth by stepper motor 98through an angular displacement that is less than the angulardisplacement that spool 214 undergoes when moving between the first andsecond positions. This rotary oscillation of spool 214 in the first andsecond directions indicated by arrow 290 produces oscillations in thepressure applied to the patient interface 22 via opening 280 of tube278. Such oscillatory movement of spool 214 can be programmed to occurwhen spool 214 is in the first position, the second position, or anyposition therebetween. That is, oscillations in the pressure can besupplied to the patient interface during insufflation, exsufflation andpauses times.

While any materials of suitable strength may be used to construct thevarious components of the rotary spool valve 88, in some embodiments,plates 224, 248 are made of aluminum; spool 214, hub 216, and plug 222are made of acetyl plastic material; element 218 and cylinder 208 aremade of acrylonitrile butadiene styrene (ABS) plastic material; manifoldblocks 210, 212 are made of acrylic plastic material; rings 264 are madeof a silicone sponge material; and conduit 272 is made of rubber.

Referring now to FIG. 22, an example of a screen shot 292 of the GUI 16is shown when the respiratory device 10 is operating in an automaticmode. Screen 292 includes a header 294 that has text indicating thatdevice 10 is operating in the automatic mode and including a patient'sname, the date and the time. Beneath the header 294 on screen 292 arenumerical values for Peak Cough Flow and Tidal Volume. The values shownare determined based on signals received by control circuitry 76 fromone or more of sensors 106 which are shown diagrammatically in FIG. 40.

Screen 292 of FIG. 22 also has a window 296 with a bar graph 298 thatindicates a programmed range of the positive insufflation pressure andthe negative insufflation pressure to be applied to the patient duringtreatment. In the illustrative example the positive insufflationpressure is programmed at 20 cmH₂O and the negative exsufflationpressure is programmed at −20 cmH₂O. As indicated in window 296, deviceis capable of being programmed to have a maximum insufflation pressureof 60 cmH₂O and a maximum (i.e., most negative) exsufflation pressure of−60 cmH₂O.

Beneath window 296 on screen 292 are three windows 298, 300, 302 whichhave information concerning the programmed settings for exsufflation,pause, and insufflation, respectively. In the illustrative example, theprogrammed 20 cmH₂O insufflation pressure is set to be applied to thepatient for 1.0 second as indicated in window 302, the −20 cmH₂Oexsufflation pressure is set to be applied to the patient for 1.0 secondas indicated in window 298, and then a pause pressure of 10 cmH₂O at aflow setting of 3 is to be applied to the patient for 2.0 seconds asindicated in window 300.

Beneath window 300 on screen 296 is a change setting button 304 that isselected by a user to re-program the operating parameters of device 10,such as those shown in windows 298, 300, 302. To the right and left ofbutton 304, respectively, is an inhale column indicator 306 that isilluminated to indicate when the insufflation pressure is being appliedto patient interface 22 by device 10 and an exhale column indicator 308that is illuminated to indicate when the exsufflation pressure is beingapplied to patient interface 22 by device 10. A footer 310 at the bottomof screen 292 includes a lock status icon 312 to indicate whether device10 is locked from use or unlocked for use, a start button 314 that istouched by a user to start device 10 operating according to theprogrammed parameters, and a help icon 316 that is selected to obtainhelp regarding the operation of device 10.

A menu 318 of icons appears in a column at the right hand side of screen292. Menu 318 includes a home icon 320 that is selected by a user toreturn to a home screen of device 10, an automatic icon 322 that isselected by a user to place device 10 in the automatic mode, a manualicon 324 that is selected by a user to place device 10 in a manual mode,a lock icon 326 that is selected by a user to lock device 10 from use(if device 10 is locked then an unlock icon appears in menu 318 in lieuof icon 326), and a general settings icon 328 that is selected by a userto adjust settings and perform various administration functions relatingto device 10.

The automatic and manual modes of device 10 are very similar to thosedescribed in U.S. Pat. No. 8,539,952 which is already incorporated byreference herein. However, one of the primary differences between thedevice of U.S. Pat. No. 8,539,952 and device 10 is that after the pauseperiod, the positive insufflation pressure is applied to patientinterface 22 in response to an inspiratory trigger being sensed by oneor more of sensor(s) 106. That is, the insufflation pressure is appliedto patient interface 22 by device 10 when the patient begins to inhale.With regard to illustrative device 10, the change from insufflation modeto exsufflation mode and then the change from exsufflation mode to pausemode are dependent upon the programmed times. However, that is not tosay that in other embodiments, device 10 could not sense an expiratorytrigger to switch from insufflation mode to exsufflation mode and/or asubsequent inspiratory trigger to switch from exsufflation mode to pausemode.

Referring now to FIG. 23, a graph 330 shows a pressure v. time curve.Along a Pressure axis of graph 330 are shown the following: anI-pressure corresponding to the insufflation pressure discussed above, aPause-pressure corresponding to the pause or rest pressure discussedabove, and an E-pressure corresponding to the exsufflation pressurediscussed above. Along a Time axis of graph 330 are shown the following:an I-time corresponding to the time during which insufflation pressureis applied by device 10, an E-time corresponding to the time duringwhich exsufflation pressure is applied by device 10, and a Pause-timecorresponding to the pause time of device 10. Graph 330 shows that theinsufflation and exsufflation together are considered to be a coughcycle according to this disclosure. Graph 330 includes a generallysinusoidal dotted line 332 superimposed on the pause pressure line toindicate that the patient breaths spontaneously for multiple breathsduring the pause time.

Referring now to FIG. 24, a graph 330′, which is similar to graph 330 ofFIG. 23, is shown. Graph 330′ indicates that the insufflation,exsufflation, and pause together are considered to be a cough therapycycle. In the illustrative example of graph 330′, the therapy applied bydevice 10 includes three cough therapy cycles. Graph 330′ also showsthat device 10 is operated to apply a sigh pressure at the end of thetreatment cycle. The sigh pressure is among the parameters that a userprograms into device 10 using GUI 16. In the illustrative example, thesigh pressure is less than the I-pressure (i.e., the insufflationpressure) and greater than the pause pressure.

Referring now to FIG. 25 a graph 330″, similar graph 330 of FIG. 23, isshown. Graph 330″ shows that device 10 is capable of producingoscillations in the pressure applied to the patient during insufflation,exsufflation and pause times. The oscillations are a result of theoscillatory movement of rotatable plate 122 in directions 204, 206relative to stationary plates 114, 118 in one embodiment as discussedabove or as a result of the oscillatory movement of rotatable spool 218in the directions indicated by double headed arrow 290 relative tostationary cylinder 208 in another embodiment as discussed above.

In some embodiments, control circuitry 76 of device 10 is programmed tostore and/or analyze data sensed by the one or more sensors 106. Forexample, FIG. 26 shows a multi-trace graph 334 including pressure, flowand volume graphs 336, 338, 340 that are viewable on the GUI 16 ofdevice 10. As another example, FIG. 27 shows a graph 342 including aspirometry curve of volumetric flow rate v. volume that is viewable onthe GUI 16 of device 10.

Referring now to FIG. 28, wireless communication module 64 of device 10is operable to send and receive data to and from a wireless access point346 which, in turn, is coupled via communication infrastructure 348 suchas the Internet 350 to one or more remote servers 352. Infrastructure348 and Internet are shown diagrammatically in FIG. 28. The doubleheaded arrows between the various components in FIG. 28 are intended torepresent the two-way communication capability between device 10 andserver(s) 352. Server 352, therefore, is at a facility that is remotefrom the facility at which device 10 is located. Server 352 iscommunicatively coupled to one or more remote computer devices 354 suchas the illustrative tablet computer, lap top computer, and smart phone.Devices 354 are configured with software to analyze or process datareceived from one or more remote respiratory devices 10. If desired,device 10 is configured to communicate wirelessly with other respiratorydevices 356 so that device 10 is able to coordinate the delivery ofmultiple types of respiratory treatment to a patient using devices 10,356.

Referring now to FIG. 29, a combination fastener/hose retention hook 358is arranged for insertion into a hole 360 provided in a portion of shell56 that serves as a back of handle 18 of the housing 12 of device 10.Hook 358 includes a hook portion 362, a non-threaded straight portion364, a threaded straight portion 366, and an enlarged shoulder portion368 that interconnects portions 364, 366. Threaded portion 366 fastensshells 54, 56 together along with other threaded fasteners (not shown).Shoulder portion 358 abuts a portion of shell 56 inside of hole 360 whenhook 358 is attached to shells 54, 56. As shown in FIG. 30, after hook358 is attached to the handle 18 of the housing 12, straight portion 364projects from hole 360 and positions hook portion 372 in elevated spacedrelation with top wall 66 of shell 56. Hook portion 372 is configured toreceive hose 20 as shown in FIG. 31, thereby to retain hose 20 in astorage position.

Referring now to FIGS. 32 and 33, an alternative hose retention device370 is mounted to top wall 66 of housing 12 of device 10 behind thehandle 18. Device 370 includes a lower portion 372 and a set of cleats374 that are grouped in pairs that project upwardly at the opposite endsof lower portion 372. Cleats 374 and lower portion 372 are shaped todefine a hose-receiving trough 376, shown in FIG. 32, that is configuredto receive hose 20 therein to retain hose 20 in a storage position asshown in FIG. 33. Hose retention device 370 is also configured to serveas a cord wrap around which power cord 84 of device 10 is able to bewrapped as shown in FIG. 33. In particular, cord 84 wraps around lowerportion 372 of device 370 beneath cleats 374.

Referring now to FIGS. 34-37, in some embodiments, a hose adapter 378 isused to connect hose 20 to port 24. Adapter is sized to slip over port24 with a slight press fit therebetween. After adapter 378 is attachedto port 24, as shown in FIG. 35, a cap 380 of adapter 378 is opened froma tubular portion 382 of adapter 378 as shown in FIG. 36. A tether 384interconnects cap 380 and tubular portion 382 so that cap 380 does notget separated from tubular portion 382 and lost after opening. After cap380 is opened, an open end of hose 20 opposite from mask 36 (ormouthpiece) is slipped over an end region of tubular portion 382 ofadapter 378 with a slight press fit therebetween. After device 10 hasbeen used for a respiratory therapy or treatment session, hose 20 isdecoupled from adapter 378 and cap 380 is moved back to the closedposition. Use of adapter 378 keeps port 24 from becoming contaminated aseasily as otherwise may occur without the use of adapter 378. In someembodiments, adapter 378 is made from a medical grade plastic materialthat can be cleaned easily.

Referring now to FIG. 38, a carrying case 386 is configured for carryingdevice 10 therein. Case 386 has a base portion 388 and a lid portion 390that is openable and closable relative to base portion 388 so thatdevice 10 can be inserted into the interior region of case 386 andremoved from case 386 as desired. A carrying handle 392 is provided at atop of case 386 for a user to grasp while carrying case 386. Lid portion390 of case 386 has a door 394 that is opened relative to a main frontpanel 396 of lid portion 390 by pivoting upwardly to provide access touser controls shown on GUI 16 of device 10 and to provide access toon/off button 28. Thus, the user inputs of GUI 16 and button 28 can beused without the need to remove device 10 from carrying case 386.

Referring now to FIG. 39, an alternative embodiment of a carrying case386′ is also configured for carrying device 10 therein. However,carrying case 386′ is configured for attachment to a wheelchair 400 andparticularly, to a rear portion of a backrest 402 of the wheelchair 400.Case 386′ has a door 394′ that is opened by pivoting downwardly relativeto a main front panel 396′ of case 386′ to provide access to usercontrols on GUI 16 of device 10 and to provide access to on/off button28 of device 10 without the need to remove device 10 from carrying case386′. In some embodiments, suitable fasteners such as snaps, zippers,straps, buckles, or hook-and-loop fasteners are provided to retain doors394, 394′ in the closed positions relative to the respective frontpanels 396, 396′.

Referring now to FIG. 41, some components of an alternative embodimentpneumatic system 574 are shown. System 574 includes a stepper motor 598,a blower 586, and a rotary valve 588. Rotary valve 588 includes a firststationary plate 500, a second stationary plate 502, a third stationaryplate 504, and a rotatable valve member or plate 506. Each of plates500, 502, 504, 506 is circular or round in shape. Plates 504, 506 aresandwiched between plates 500, 502. Second stationary plate 502 has anannular rim 508 that surrounds an outer periphery 510 of thirdstationary plate 504 and an outer periphery 512 of rotatable plate 506.Second stationary plate 502 also includes an annular flange 514 thatprojects radially outwardly from annular rim 508. Annular flange 514 isfastened to first stationary plate 500 such as by gluing or welding, forexample.

First stationary plate 500 has four holes 520 a, 520 b, 520 c, 520 d;second stationary plate 502 has four holes 522 a, 522 b, 522 c, 522 d;and third stationary plate 504 has four holes 524 a, 524 b, 524 c, 524d. Holes 520 a-d, 522 a-d, and 524 a-d are aligned with each other. Thatis the “a-series” holes of plates 500, 502, 504 are aligned; the“b-series” holes of plates 500, 502, 504 are aligned; the “c-series”holes of plates 500, 502, 504 are aligned; and the “d-series” holes ofplates 500, 502, 504 are aligned.

Third stationary plate 504 is formed to include four tubular portions526 a, 526 b, 526 c, 526 d. Tubular portions 526 a-d define, in part,the holes 524 a-d, respectively, that extend though plate 504. Eachtubular portion 526 a-d is in registry with, such as by being receivedwithin, a respective hole 522 a-d of the four holes 522 a-d of thesecond stationary plate 502. Valve 588 includes four springs 528. Eachspring 528 of the four springs 528 is mounted on a respective tubularportion 526 a-d of the four tubular portions 526 a-d. Spring 528,therefore, are situated between second stationary plate 502 and thirdstationary plate 504 to bias the third stationary plate 504 againstrotatable plate 506 which, in turn, biases rotatable plate 506 againstfirst stationary plate 500. Thus, third stationary plate 504 issometimes referred to herein as a biasing plate.

Still referring to FIG. 41, a valve shaft 530 mounts to an output shaft532 of stepper motor 598. A hub 534 at a distal end of shaft 532attaches to a central region of 536 of rotatable plate 506 by suitablefasteners such as bolts that are received in apertures 538 of plate 506and apertures 540 of hub 534. Rotatable plate 506 has four holes 542 a,542 b, 542 c, 542 d. Stepper motor 598 acts through shafts 530, 532 torotate plate 506 so that various ones of holes 542 a-d of rotatableplate 506 are aligned or misaligned with various ones of holes 520 a-d,522 a-d, 524 a-d of stationary plates 500, 502, 504. Thus, thediscussion above regarding the operation of valve 88 of pneumatic system74 to produce positive pressure, negative pressure, and oscillatorypressure at port 24 and therefore, within patient interface 22, isequally applicable to valve 588 of pneumatic system 574. That discussionis not repeated for the sake of brevity. Suffice it to say thatrotatable plate 506 has a first position in which positive pressure fromblower 586 is delivered to port 24 and a second position in whichnegative pressure from blower 586 is delivered to port 24. Plate 506 canbe oscillated back and forth by stepper motor 598 with respect to thefirst position and with respective to the second position to produceoscillations in the pressure, be it positive or negative, provided atport 24.

Unlike pneumatic system 74 which has manifold blocks 116, 120, pneumaticsystem 574 has individual tubular manifold elements. In particular, afirst manifold tube 544 has an inlet passage 546 coupled to an outlet592 of blower 586 and a pair of outlet passages 548 a, 548 b coupled toholes 520 a, 520 b, respectively, of first stationary plate 500.Similarly, a second manifold tube 550 has an outlet passage 552 coupledto an inlet of blower 586 (not shown but similar to inlet 90 of blower86) and a pair of inlet passages 548 c, 548 d coupled to holes 520 c,520 d, respectively, of first stationary plate 500. At the opposite sideof valve 588, a third manifold tube 554, a fourth manifold tube 556, anda fifth manifold tube 558 are provided. Tube 554 has a passage 560 thatcouples to hole 522 a of plate 502; tube 556 has a passage 562 thatcouples to holes 522 b, 522 c of plate 502 through respective ports oftube 556; and tube 558 has a passage (not shown, but similar to passage560 of tube 554) that couples to hole 522 d of plate 502.

Tube 556 couples to the patient port 24 of respiratory device 10 fordelivery of positive pressure or negative pressure to port 24 dependingupon the position of rotatable plate 506. Tubes 554, 558 are eachcoupled to ambient atmosphere. Manifold tubes 544, 550, 554, 556, 558are fixed to the respective stationary plates 400, 502 via suitablefastening mechanisms such as glue or welding, for example. In someembodiments, tubular portions 526 a-d project through holes 522 a-d tobe received in the respective passages of manifold tubes 554, 556, 558.

Referring now to FIGS. 42-46, some components of an alternativeembodiment pneumatic system 674 are shown. System 674 includes a steppermotor 698, a blower 686, and a rotary valve 688. Rotary valve 688includes a first stationary plate 600, a second stationary plate 602,and a rotatable valve member or plate 606 as shown in FIG. 42. Bothstationary plates 600, 602 are circular or round in shape. However,unlike valves 88, 588 which have circular rotatable valve plates 122,506, respectively, the rotatable plate 606 of valve 688 is bow-tieshaped as best shown in FIG. 43. Plate 606 is sandwiched between plates600, 602. First stationary plate 600 has an annular rim 608 with an edge610 that abuts plate 602. Rim 608 surrounds rotatable plate 606.

First stationary plate 600 has four holes 620 a, 620 b, 620 c, 620 d andsecond stationary plate 602 has four holes 622 a, 622 b, 622 c, 622 d.Holes 620 a-d, 622 a-d are aligned with each other. That is the“a-series” holes of plates 600, 602 are aligned; the “b-series” holes ofplates 600, 602 are aligned; the “c-series” holes of plates 600, 602 arealigned; and the “d-series” holes of plates 600, 602 are aligned. Plate606 has first and second wing portions 612, 614 connected by a hubportion 616 as shown in FIG. 43. Wing portions 612, 614 are each boundedby an arcuate edge 626, a first straight edge 628, and a second straightedge 630. Edges 628, 630 extending radially with respect to a center ofhub 616 which is bounded by generally arcuate edges 633. Hub 616 has anon-round aperture 632 which, in the illustrative embodiment, isgenerally square-shaped with chamfered corner regions. The radii ofcurvature of edges 626, 633 are centered at the center of hub 616. Wingportions 612, 614 are sized and shaped such that each edge 630 isangularly spaced from its corresponding edge 630 by about 90 degrees.

Hub 616 of plate 606 is keyed to an output shaft of stepper motor 698 orto an extension shaft that couples to the output shaft of stepper motor698. For example, a portion of the shaft received within aperture 632 iscomplementary in shape to the shape of aperture 632. Thus, plate 606rotates with the output shaft of stepper motor 698. Stepper motor 698rotates plate 606 so that wing portions 612, 614 of rotatable plate 606are aligned or misaligned with various ones of holes 620 a-d, 622 a-d ofstationary plates 600, 602. Thus, the discussion above regarding theoperation of valve 88 of pneumatic system 74 and of valve 588 ofpneumatic system 574 to produce positive pressure, negative pressure,and oscillatory pressure at port 24 and therefore, within patientinterface 22, is equally applicable to valve 688 of pneumatic system674. That discussion is not repeated for the sake of brevity. Suffice itto say that rotatable plate 606 has a first position, shown in FIG. 44,for example, in which positive pressure from blower 686 is delivered toport 24 and a second position, shown in FIG. 45, for example, in whichnegative pressure from blower 686 is delivered to port 24. Plate 606 canbe oscillated back and forth by stepper motor 698 with respect to thefirst position and with respective to the second position to produceoscillations in the pressure, be it positive or negative, provided atport 24. Plate 606 can also be moved to a neutral position, shown inFIG. 46, for example, in which substantially equal amounts of positiveand negative pressure are applied to port 24 thereby to cancel eachother out to have a net effect of substantially zero at port 24.

Unlike pneumatic system 74 which has manifold blocks 116, 120 and unlikepneumatic system 574 which has individual manifold tubes 544, 550, 554,556, 558, system 674 has a first molded or cast manifold portion orshell 650 and a second molded or cast manifold portion or shell 652.Manifold shells 650, 652 are monolithic pieces that contain all of thepassages that couple to holes 620 a-d of stationary plate 600, in thecase of shell 650, and to holes 622 a-d of plate 602, in the case ofshell 652. In FIG. 42, a passage 654 of shell 650 which couples topatient port 24 can be seen. Passage 654 is defined by a tubular portion655 of shell 650. It should be understood that shell 650 has one or moreother passages (not shown) that communicate with atmosphere. Also inFIG. 42, passages 656, 658 of shell 652 can be seen. Passages 656, 658are defined by tubular portions 657, 659 of shell 652, respectively.

Tubular portion 657 and its associated passage 656 of shell 652 coupleto a positive pressure outlet 692 of blower 686 via a first conduit 660.Similarly, tubular portion 659 and its associated passage 658 of shell650 couple to the negative pressure inlet 690 of blower 686 via a secondconduit 662. Passage 656 of manifold shell 652 is in pneumaticcommunication with holes 622 c, 622 d of stationary plate 602 andpassage 658 of manifold shell 652 is in pneumatic communication withholes 622 a, 622 b of stationary plate 602. Manifold shell 652 has apair of tubular connecting portions 664 in this regard.

Suitable fasteners (not shown) such as bolts or screws (these terms areused interchangeably herein) are provided to couple manifold shells 650,652 together. In this regard, shell 650 has ears 668 with apertures 670and shell 652 has ears 672 with screw-receiving bosses 674. When shells650, 652 are fastened together, plates 600, 602, 606 are sandwichedtherebetween. A set of dowel pins 676 extend from shell 650 and arereceived in apertures 678 provided in plate 600. A similar set of dowelpins (not shown) extending from shell 652 are received in apertures 678provided in plate 602. Receipt of the dowel pins 676 in apertures 678 ofplates 600, 602 prevents plates from rotating relative to respectiveshells 650, 652. The dowel pins 676 do not extend into the space betweenplates 600, 602 so as not to interfere with rotation and oscillation ofbow-tie shaped plate 606 within the space between stationary plates 600,602. Fasteners such as screws or bolts (not shown) are also provided tocouple stepper motor 698 to manifold shell 650. In this regard, a plate680 of stepper motor 698 has apertures 682 and manifold shell 650 hasscrew-receiving bosses 684 for receipt of such fasteners.

Referring now to FIG. 72, some components of an alternative embodimentpneumatic system 774 are shown. System 774 includes a stepper motor 798,a blower 786, and a rotary valve 788. Rotary valve 788 includes a firststationary plate 700, a second stationary plate 702, and a rotatablevalve member or plate 706 as shown in FIG. 42. Plates 700, 702, 706 areeach circular or round in shape. Plate 706 is sandwiched between plates700, 702. First stationary plate 700 has an annular rim 708 with an edge710 that abuts plate 702. Rim 708 surrounds rotatable plate 706.

First stationary plate 700 has four holes 720 a, 720 b, 720 c, 720 d;second stationary plate 702 has four holes 722 a, 722 b, 722 c, 722 d;and rotatable plate 706 has four holes 724 a, 724 b, 724 c, 724 d. Holes720 a-d, 722 a-d are aligned with each other. That is the “a-series”holes of plates 700, 702 are aligned; the “b-series” holes of plates700, 702 are aligned; the “c-series” holes of plates 700, 702 arealigned; and the “d-series” holes of plates 700, 702 are aligned. Anoutput shaft extension 732 of stepper motor 798 has a non-round tip 734which is received in a complementarily shaped non-round aperture 736provided at the center of rotatable plate 706. Thus, plate 706 rotateswith output shaft extension 732 of stepper motor 798. Extension 732 ismounted on an output shaft (not shown) of stepper motor 798.

Stepper motor 798 acts through shaft 732 to rotate plate 706 so thatvarious ones of holes 724 a-d of rotatable plate 706 are aligned ormisaligned with various ones of holes 720 a-d, 722 a-d of stationaryplates 700, 702. Thus, the discussion above regarding the operation ofvalve 88 of pneumatic system 74 and of valve 588 of pneumatic system 574to produce positive pressure, negative pressure, and oscillatorypressure at port 24 and therefore, within patient interface 22, isequally applicable to valve 788 of pneumatic system 774. That discussionis not repeated for the sake of brevity. Suffice it to say thatrotatable plate 706 has a first position in which positive pressure fromblower 786 is delivered to port 24 and a second position in whichnegative pressure from blower 786 is delivered to port 24. Plate 706 canbe oscillated back and forth by stepper motor 798 with respect to thefirst position and with respective to the second position to produceoscillations in the pressure, be it positive or negative, provided atport 24.

Similar to system 674, system 774 has a first molded or cast manifoldportion or shell 750 and a second molded or cast manifold portion orshell 752. Manifold shells 750, 752 are monolithic pieces that containall of the passages that couple to holes 720 a-d of stationary plate700, in the case of shell 750, and to holes 722 a-d of plate 702, in thecase of shell 752. Unlike shells 650, 652 described above, shells 750,752 have oblong openings 712 that communicate with respective pairs ofholes 720 a-d, 722 a-d. Gaskets 714 are provided around oblong openings712 to seal against respective stationary plates 700, 702. A largeO-ring type gasket 716 provides a seal between manifold shells 750, 752.Gasket 716 encompasses a periphery of rotatable 706.

In FIG. 72, a passage 754 of shell 750 which couples to patient port 24can be seen. Passage 754 is defined by a tubular portion 755 of shell750. Shell 750 also has a passage 744 defined by a tubular portion 745that communicates with atmosphere. Passage 754 of tubular portion 755 ofmanifold shell 750 communicates with holes 720 a, 720 d of stationaryplate 700 through an associated oblong opening 712 and passage 744 oftubular portion 745 of manifold shell 750 communicates with holes 720 b,720 c of stationary plate 700 through an associated oblong opening 712.Also in FIG. 72, passages 756, 758 of shell 752 can be seen. Passages756, 758 are defined by tubular portions 757, 759 of shell 752,respectively. Passage 756 of tubular portion 757 of manifold shell 752communicates with holes 722 c, 722 d of stationary plate 702 through anassociated oblong opening (not shown, but similar to passages 712 ofshell 750) and passage 758 of tubular portion 759 of manifold shell 752communicates with holes 722 a, 722 b of stationary plate 700 through anassociated oblong opening (not shown, but similar to passages 712, ofshell 750). Manifold shell 752 has a pair of tubular connecting portions764 in this regard to communicate with the oblong openings. Tubularportion 757 and its associated passage 756 of shell 752 couples to apositive pressure outlet of blower 786 via a first conduit 760.Similarly, tubular portion 759 and its associated passage 758 of shell752 couples to the negative pressure inlet of blower 786 via a secondconduit 762.

Suitable fasteners such as bolts or screws 792 and nuts 794 are providedto couple manifold shells 750, 752 together. In this regard, shell 750has ears 768 with apertures 770 and shell 752 has ears 774 withnut-receiving bosses 772. Bolts 792 extend through ears 768, 774 arethreaded into nuts 794 which are received in bosses 772. When shells750, 752 are fastened together, plates 700, 702, 706 are sandwichedtherebetween. Fasteners such as screws or bolts 796 are also provided tocouple stepper motor 798 to manifold shell 750. In this regard, a plate780 of stepper motor 798 has apertures 782 and manifold shell 750 hasscrew-receiving bosses 784 for receipt of fasteners 796. Screws 793extend through apertures 795 to couple plate 780 of stepper motor 798.

In some embodiments, blower 786 is a model no. U85MX-024KX-4 bloweravailable from Micronel AG of Tagelswangen, Switzerland and steppermotor 798 is of the type available from Shinano Kenshi Corporation ofCulver City, Calif. Plate 780 of stepper motor 798 is made of metal,such as stainless steel or aluminum, and motor shaft extension 732 ismade of aluminum in some embodiments. Manifold shells 750, 752 aresometimes referred to as manifold “cases” and are made of a plasticsmaterial such as a polycarbonate (PC)/acrylonitrile butadiene styrene(ABS) compound which, in some embodiments, comprises General Electric(GE) CYCOLOY™ CX2244ME material. Stationary plates 700, 702 are made ofstainless steel in some embodiments. Rotatable plate 706 is made of aplastics material such as polycarbonate with 15% polytetrafluoroethylene(PTFE) which, in some embodiments, comprises LNP™ LUBRICOMP™ DL003EXJmaterial. O-ring 716 is made of a silicone sponge material or silicon insome embodiments. Conduits 760, 762 are made of silicone rubber, such asa silicone rubber elastomer having a hardness of shore 50-57 A, in someembodiments. Gaskets 714 are made of a soft silicone having a durometerof A50. Fasteners 792, 794, 795 are made of metal such as stainlesssteel or aluminum in some embodiments. The above-listed component partnumber and materials are examples of suitable parts and materials and isnot intended to be limiting in any way.

Referring now to FIGS. 73-76, a respiratory device 10′ is provided andis very similar to device 10 described above. Thus, like referencenumbers are used in describing device 10′ as appropriate. Device 10′includes a housing 12 having a sloped upper front wall portion 14 a onwhich a graphical user interface 16 is accessible to enter user inputsinto device 10 and to see displayed information regarding the operationof device 10′ as shown in FIG. 73. Housing 12 of device 10′ also has asloped bottom front wall portion 14 b which slightly curves downwardlyand rearwardly from the bottom of wall 14 a.

A port 24 extends from an annular recess 800 provided in front wallportion 14 b. Port 24 is referred to herein as a hose port or patientport, for example. Similar to device 10, device 10′ is operable as aninsufflation/exsufflation device (aka a cough assist device) and is alsooperable to deliver other respiratory therapies such as continuouspositive expiratory pressure (CPEP) and continuous high frequencyoscillation (CHFO), just to name a couple. A manual on/off button 802 isprovided on front wall portion 14 a beneath display 16 and above port 24of wall portion 14 b. Button 802 and port 24 are centered on theirrespective front wall portions between the opposite sidewalls 58 ofdevice 10′. Unlike filter unit 40 of device 10, which is locatedadjacent mask 36, device 10′ has a filter unit 840 which connects toport 24 and hose 20 connects to filter port 840 as shown in FIG. 73.Filter unit 840 is described in more detail below in connection withFIGS. 53-55.

Referring now to FIG. 74, a top wall 66 of housing 12 of device 10′ hasa U-shaped handle recess 804 that receives a pivotable U-shaped handle18′ therein when handle 18′ is in a storage position. Handle 18′ pivotsupwardly from its storage position toward front wall 14 a of housing 12so that a user is able to grasp a central region of handle 18′ to carrydevice 10′. A back wall 68 of housing 12 if device 10′ has a course airfilter 806 through which air passes to reach the blower, such as blower786, carried inside housing 12. Back wall 68 of device 10′ includeshorizontally oriented cooling vents 808 which cover elongated slots (notshown) through which ambient air enters and exits the interior region ofhousing 12 to cool the various electrical components, such as controlcircuitry 76 and stepper motor 798, contained in the interior region.Ventilation recesses 810 are provided in each of side walls 58 of device10′ to permit similar ambient air flow into and out of the interiorregion of housing 12 at the sides of device 10′.

A power cord 812 attaches to a power port 814 which is provided on backwall 68 of housing 12 of device 10′ beneath course air filter 806. Cord812 has a plug at its opposite end (not shown) which plugs into astandard AC power outlet (not shown) to provide power to device 10′ in aknown manner. Other connection ports are provided near a bottom of backwall 68 including a pulse oximeter (SpO2) port 816 to which a pulseoximeter couples, if desired; a foot on/off switch port 818 to whichcoupler 32 of foot switch controller 34 (see FIG. 1) couples, ifdesired; and a pair of Universal Serial Bus (USB) ports 820 for couplingof other peripheral devices, if desired. Ports 814, 816, 818, 820 areeach electrically coupled to the control circuitry 76 contained in theinterior region of housing 12 of device 10′. In some embodiments, anebulizer port, similar to ports 814, 816 or similar to USB ports 920,is provided for coupling to an electrically operated nebulizer such asthose described elsewhere herein.

In the illustrative example of device 10′, a first shroud 822 projectsfrom back wall 68 above coarse air filter 806, a second shroud 824projects from back wall 68 above power port 814, and a third shroud 826projects from back wall 68 above ports 816, 818, 820. Shrouds 822, 824,826 are each generally upside down U-shaped and provide a modicum ofshielding and protection for filter 806 and ports 814, 816, 818, 820such as to prevent falling objects or debris from inadvertentlycontacting filter 806 and ports 814, 816, 818, 820. Back wall 68 ofdevice 10′ also includes a battery cover 828 which is removable toexpose a battery compartment (not shown) in which batteries (not shown)are situated for powering device 10′ when power cord 812 is not pluggedinto an AC power outlet. FIGS. 75 and 76 show the overall dimension ofdevice 10′. Thus, a width of device 10′ is 8.6 inches (21.844centimeters), the height of device 10′ is 8.5 inches (21.59centimeters), and the depth of device 10′ is 7.2 inches (18.288centimeters).

Referring now to FIG. 53, in some embodiments of device 10′, filter unit840 has an inlet tube 842 which attaches to port 24, such as with apress fit, and an outlet tube 844 to which hose 20 couples, such as witha press fit. In the illustrative example, an oxygen inlet tube 846 isprovided at tube 842 for coupling to a source of oxygen and an oxygenmeasurement tube 848 is provided at tube 844 for coupling to an oxygenmeasurement device which, for example, measures a concentration ofoxygen within the stream of air flowing through filter unit 840 andentering hose 20 for ultimately delivery to the patient. Tubes 846, 848tap into respective tubes 842, 844 at right angles in the illustrativeexample, but this need not be the case. Tubes 846, 848 are located onopposite sides of a filter housing 850 in which a filter 852 is carried.Filter 852 is an anti-bacterial filter in some embodiments. Caps,clamps, plugs, or other mechanisms for blocking air flow through tubesto close off tubes 846, 848 when an oxygen source is not coupled to tube846 are contemplated by this disclosure.

Referring now to FIG. 47, housing 12 of device 10′ is shown with topwall 66 and back wall 68 omitted to expose the internal region ofhousing 12. Thus, circuit boards 76 a, 76 b, 76 c of control circuitry76 can be seen in FIG. 47. In the illustrative embodiment of device 10′,pneumatic system 774 is situated in the interior region of housing 12.Thus, blower 786, rotary valve 788, and stepper 798 can also be seen inFIG. 47. A cylindrical motor housing portion 799 of blower 786 iscradled and supported by a vertically oriented U-shaped plate 830 which,in turn, is supported with respect to a bottom wall 832 of housing 12 bya Z-shaped bracket 834. Rotary valve 788 is cradled and supported by ablock 836 which, in turn, is supported with respect to bottom wall 832by an L-shaped bracket 838. Stepper motor 798 is supported by a block837 that rests atop an upper horizontal wall of a C-shaped bracket 835.A bottom horizontal wall of C-shaped bracket 835 is supported withrespect to bottom wall 832 of housing and circuit board 76 c is attachedto a vertical wall of C-shaped bracket 835.

Referring now to FIGS. 48-52, a handset 900 for use with respiratorydevices 10, 10′ is shown. Handset 900 may be used in lieu of mask 36 orin addition to mask. When used with mask 36, a cylindrical outlet end902 of handset 900 is coupled to mask 36 and a cylindrical inlet end 904is coupled to filter unit 40, in the case of device 10, or is coupled tohose 20, in the case of device 10′. When handset 900 is used withoutmask 36, a disposable mouthpiece is attached to end 902 and projectstherefrom for receipt in the patient's mouth as is well known in theart. Thus, end 902 has a standard 22 millimeter diameter for interfacingwith known mouthpieces used with respiratory devices.

Handset 900 includes a generally banana-shaped tube 906 that has anupper surface 908 which is generally convex from end-to-end of thegenerally banana-shaped tube 906 and a bottom surface 910 which isgenerally concave from end-to-end of the generally banana-shaped tube906. Side surfaces 909 interconnect top and bottom surfaces 908, 910 asshown in FIG. 50. Ends 902, 904 of generally banana-shaped tube 906 areopen so that inhaled and exhaled gases are free to flow through tube 906between ends 902, 904.

Handset 900 has a nebulizer port 911 provided at an apex 914 of uppersurface 908 such that, in use, a nebulizer extends upwardly from a topof the handset 900. The apex 914 may generally be thought of as theuppermost region of surface 908 when tube 906 is placed on a horizontalsurface with bottommost portions of ends 902, 904 engaging thehorizontal surface. It is contemplated that an electrically operatedvibrating plate or vibrating mesh nebulizer, such as nebulizer 44 ofFIG. 1, for example, is used with handset 900 and is attached to port911 so that nebulized medication is forced into the interior region oftube 906. In some embodiments, port has a 22 millimeter inside diametersuch that a nebulizer available from Aerogen Ltd. of Galway, Ireland,for example, is coupleable to port 911. Because the nebulizer port 911is at the apex 914 of tube 906, gravity assists in moving the nebulizedmedication downwardly into tube 906 and into the stream of gas movingthrough tube 906 from end 904 to end 902 and ultimately to the patient.

In the illustrative embodiment, handset 900 includes a plug 916 thatcloses nebulizer port 911 when the nebulizer is absent. Nebulizer port911 includes a cylindrical wall 918 that projects into an interiorregion of the generally banana-shaped tube 906 as shown in FIGS. 49 and50. In the illustrative example, nebulizer port 911 includes an annularridge 912 that extends upwardly from the apex of the upper surface 908of tube 906. Plug 916 includes a grip tab 920 which is grabbed by a userto remove and install plug 916 with respect to port, an annular flange922 which seats against a top edge of annular ridge 912 when plug 916 isinstalled in port 911, and a cylindrical wall 924 that extendsdownwardly from flange 922 to contact wall 918 and fill port 911. Insome embodiments, handset 900 is made of a relatively hard plasticsmaterial and plug 916 is made of softer plastics material or anelastomeric material such as rubber.

As shown in FIGS. 51 and 52, handset 900 has an aperture 926 thatextends through the generally banana-shaped tube 906 adjacent the openend 904 of the generally banana-shaped tube 906. Handset 900 also has aring 928 which is rotatable between a first position in which aperture926 is open to atmosphere and a second position in which aperture 926 isclosed. Tube 906 has a frustroconical region or wall 930 and acylindrical region or wall 932 interconnecting region 930 andcylindrical end 904. Aperture 926 is fashioned as an open slot locatedat the upper surface 908 of tube 906 and bridging across the interfacebetween frustroconical region 930 and cylindrical region 932. In theillustrative example, slot 926 is oriented in a longitudinal dimensionof the generally banana-shaped tube 906. Tube 906 has a first annularshoulder 934 that provides a transition between the main body of tube906 (i.e., the part of tube 906 having nebulizer port 911) andfrustroconical region 930. Tube 906 also has a second annular shoulder936 that provides a transition between cylindrical region 932 andcylindrical end 904.

In the illustrative embodiment, ring 928 includes a sleeve 938 thatwraps around a majority of the circumference of regions 930, 932 of thegenerally banana-shaped tube 906 in abutting rotative bearing engagementtherewith. Thus, sleeve 938 includes a frustroconical portion 940 and acylindrical portion 942 which are complimentary in shape to regions 930,932 of tube 906, respectively. Ring 928 also has an offset portion 944that is coupled to the sleeve 938 and that defines a channel 946 whichaligns with aperture 926 when ring 928 is in the first position so thataperture 926 and interior region of tube 906 may communicate withatmosphere through channel 946 and that is out of alignment with theaperture 926 when the ring is in the second position. Thus, aperture 926is closed off by sleeve 938 when ring 928 is in the second position.

Tube 906 has a circumferential groove 948 formed around region 932adjacent shoulder 936. Sleeve 938 of ring 928 has a set of tabs 950 thatproject into groove 948 when ring 928 is mounted to tube 906. Receipt oftabs 950 in groove 948 retains ring 928 on the generally banana-shapedtube 906. When ring 928 is mounted to tube 906, an annular ridge 952 atan end of region 940 lies adjacent to shoulder 934 with little, if any,clearance therebetween. Tube 906 has first and second depressions 954(only one of which can be seen in FIG. 51) and ring 928 includes aflexible finger 956 having a detent 958 which is received in the firstdepression 954 when ring 928 is in the first position and which isreceived in the second depression 954 when ring 928 is in the secondposition. Thus, receipt of detent 958 in depressions 954 has a tendencyto retain ring 928 in the respective first or second position dependingwhich of the two depressions 954 receives detent 958. In theillustrative embodiment, ring 928 includes a finger tab 960 that extendsoutwardly from the offset portion 944. Finger tab 960 is used to rotatering 928 relative to regions 930, 932 of the generally banana-shapedtube 906 between the first and second positions.

Referring now to FIGS. 54 and 55, in some embodiments, filter unit 840has one or more prongs extending with respect to an end 854 of tube 842.In the illustrative example, three prongs 856 a, 856 b, 856 c areincluded in filter unit 840 as shown in FIG. 54. Prongs 856 a, 856 b,856 c extend generally axially with respect to filter housing 850 whichis sometimes referred to herein as a filter carrier 850. Housing 12 ofdevice 10′ has a port wall 858 defining a back of annular recess 800.Three prong-receiving apertures 860 a, 860 b, 860 c are provided in wall858 for receipt of prongs 856 a, 856 b, 856 c, respectively.

In the illustrative example, prongs 856 a, 856 b, 856 c are spaced by120 degrees about the periphery of tube 854 and apertures 860 a, 860 b,860 c are spaced by 120 degrees about port 24. A tab or rib 862 extendsradially outwardly from port 24 by a slight amount and tube 854 has aslot or channel 864 in which tab 862 is received to properly orientfilter unit 840 with respect to port 24 so that prongs 856 a, 856 b, 856c are properly aligned with respective apertures 860 a, 860 b, 860 cduring attachment of filter unit 840 to port 24.

In the interior region of housing 12 of device 10′ behind port wall 858,three switches 866 are provided with each switch 866 being accessiblethrough a respective one of apertures 860 a, 860 b, 860 c as shown inFIG. 55 with regard to two switches 866. Switches are electricallycoupled, such as by hardwired connection, to control circuitry 76 ofdevice 10′. Control circuitry 76, therefore, receives signals fromswitches 866 to indicate an on or off state of the switches 866 (aka aclosed or open state). Switches 866 are normally in the open or offstate in the absence of filter unit 840 being attached to port 24. Whenfilter unit 840 is coupled to port 24 and prongs 856 a, 856 b, 856 cextend through apertures 860 a, 860 b, 860 c by a sufficient amount,switches 866 are moved to the on or closed state.

An annular rib 868 is provided in the bore of tube 842, as shown in FIG.55. Rib 868 engages an annular end surface 870 of port 24 to stop themovement of tube 842 relative to port during installation of filter unit840 onto port 24. When rib 842 engages surface 870, prongs 856 a, 856 b,856 c are properly positioned to close switches 866. Thus, rib 868protects prongs 856 a, 856 b, 856 c by preventing tube 842 from beingpushed too far onto port 24. In some embodiments, port 24 and tube 842are sized and configured according to the ISO 5356 standard for matingforce and engagement.

In some embodiments, the pressure source of device 10′, such as blower786 is disabled from operation unless the at least one of switch 866 isactivated (e.g., by being in the on or close state). Thus, controlcircuitry 76 of device 10′ is configured to prevent operation of blower786 unless at least one of switches 866 is in the on state. It iscontemplated by this disclosure that filter units 840 of different typesof patient interfaces 22 may have a different number of prongs 856 a,856 b, 856 c. It should be appreciated that seven permutations ofpatient interfaces 22 are possible with three switches 866 as follows:

(i) Interface 1 has only one prong 856 a;

(ii) Interface 2 has only one prong 856 b;

(iii) Interface 3 has only one prong 856 c;

(iv) Interface 4 has only two prongs 856 a, 856 b;

(v) Interface 5 has only two prongs 856 a, 856 c;

(vi) Interface 6 has only two prongs 856 b, 856 c; and

(vii) Interface 7 has all three of prongs 856 a, 856 b, 856 c.

Depending upon which of switches 866 are closed and which are opened,control circuitry 76 is able to discern which type of patient interfaceis coupled to device 10′. However, by determining that at least one ofswitches 866 is closed, control system 76 of device 10′ is generallyassured that a filter unit 840 with corresponding filter 852 is present,such that operation of blower 786 is enabled. With filter 852 present,inadvertent foreign objects are unable to pass from device 10′ to thepatient through patient interface 22. This safety feature preventsdevice 10′ from operating if hose 20 is coupled directly to port 24without any filter unit 840 being present. In some embodiments, if noneof switches 866 are closed, a message is displayed on screen 16 toremind the user to include filter unit 840 in the patient interface 22being used with device 10′. In some embodiments, two of switches 866 arerequired to be closed by at least two prongs 856 a, 856 b, 856 c beforeblower 786 is enabled for operation. In such embodiments, only fourpermutations of patient interface types is possible (e.g., choices(iv)-(vii) in the list above).

In some embodiments, it is contemplated that therapy mode options thatmay be delivered through outlet port 24 by device 10′ may be differentdepending upon which type of patient interface 22 is coupled to theoutlet port 24 as indicated by switch 866 closures. For example, patientinterfaces 22 with a mask 36 may be required for device 10′ to deliverMIE therapy to a patient by device 10′ and handset 900 may be requiredfor device 10′ to deliver CPEP or CHFO therapy to a patient. A patientinterface 22 with both a mask 36 and handset 900 may permit device 10′to deliver MIE, CPEP and CHFO therapies to a patient, just to giveanother example. In some embodiments, device 10′ may include a userinput operable to signal the controller 76 to override the disabling ofthe pressure source 786 when none of switches are activated, thereby topermit the pressure source 786 to operate even if no switches 866 areactivated. For example, such a user input may be an input on graphicaldisplay screen 16 such as one or more icons or buttons. Alternatively oradditionally, this sort of override user input may be provided as amanual switch or button on housing 12 of device 10′.

As mentioned above, device 10 senses an inspiratory trigger inconnection with delivery of automatic MIE therapy to a patient. Device10′ also has this feature. According to this disclosure, sensors 106 ofdevices 10, 10′ include at least one pressure sensor and at least onflow sensor. In some embodiments, two pressure sensors are provided soas to be compliant with the ISO 80601-2-12:2011 standard relating tocritical care ventilators. However, this need not be the case in otherembodiments. In some embodiments, the following software algorithm isexecuted by control circuitry 76 of devices 10, 10′ in connection withthe inspiratory trigger:

1. //Read the Pressure and Flow Store it in Array Flow[n] ; Pressure[n]2. If Number_of_Samples > 10 // Calculate the last 10 sample averageFlow_Average[n] = Average (Flow[n]+Flow[n− 1]+....+Flow[n−9])Pressure_Average[n] = Average (Pressure[n]+Pressure[n−l]+....+Pressure[n−9]) 3. // Calculate the First Order Difference ofFlow and Pressure Flow_Difference_Array[n] = Flow_Average[n] −Flow_Average[n−1] Pressure_Difference_Array[n] = Pressure_Average[n] −Pressure_Average[n−1] 4. If(Flow_Difference_Array[n]) > 0.1 // possiblytrigger has begun here; Store this index as “Trigger_Began_here”temp_flow_sum = temp_flow_sum + Flow_Difference_Array[n] // keepaccumulating the incremental difference in flow if(temp_flow_sum) >FLOW_SENSITIVITY // Possibly could be a trigger, confirm if pressure isdropped temp_press_sum = Sum(Pressure_Difference_Array[n] +Pressure_Difference_Array[n1]+.....Pressure_difference_Array[Trigger_Began_here]) if(temp_press_sum <0) // patient's breathing pattern always creates negative pressure ANDif(Flow[n] > FLOW_SENSITIVITY // is current flow value greater thansensitivity Trigger_Found = True else temp_flow_sum = 0Trigger_Began_here = 0

A flow chart illustrative of the preceding algorithm is shown in FIG.68. At block 970 of FIG. 68, control circuitry 76 first readssensitivity and sets a base pressure prior to starting the inspiratorytrigger algorithm. After reading the sensitivity and setting the basepressure, the inspiratory trigger sensing algorithm starts as indicatedat block 972. Once started, control circuitry 76 reads flow and pressurefrom sensors 106 at 5 millisecond sampling times as indicated at block974. Control circuitry 76 implements a 10-point (i.e., 10 samples)moving average filter for pressure and flow data points as indicated atblock 976. Control circuitry 76 then implements a first order differencefilter for the pressure and flow samples as indicated at block 978. Thefirst order differences of pressure and flow are accumulated by controlcircuitry 76 as indicated at block 980. Control circuitry 76 thencompares the accumulated pressure and flow differences to thesensitivity to see if either of them are greater than the sensitivity asindicated at block 982.

If accumulated pressure and flow differences are not greater than thesensitivity at block 982, then the algorithm loops back to block 974 andproceeds from there. If accumulated pressure and flow differences aregreater than the sensitivity at block 982, the control circuitry 76starts the blower (e.g., operates the blower as necessary to achieve theprogrammed positive pressure inspiratory pressure for automatic MIEtherapy) as indicated at block 984. The algorithm then waits for 250milliseconds as indicated at block 986 and proceeds to check todetermine if the mask 36 is removed from the patient (e.g., open to air)as indicated at block 988. If the mask 36 is not removed from thepatient as determined at block 988, then the algorithm waits for theinspiratory time of the automatic MIE therapy to expire as indicated atblock 990. If the mask 36 is removed from the patient as determined atblock 988, then control circuitry 76 proceeds to stop the blower 786from operating as indicated at block 992 and provides a visualindication of the mask removal on display 16 as indicated at block 994.

In connection with block 988 of the algorithm of FIG. 68, the followingsoftware algorithm is executed by control circuitry 76 of devices 10,10′ in connection with determining mask removal:

// Assumption Trigger_Found - true 1. Read Flow : Flow[n] 2. Calculateopen_flow // based on drive voltage 3. If(Flow[n] >= open_flow) // couldbe a false effort, but could also be a HIGH breathing effort so don'tmake decision immediately that mask is open Confidence = confidence + 1If(Confidence > 50) // for 5ms sampling time, translates to about 250msdelay in turning off the blower Turn_off_Blower( )

If the mask 36 is disconnected or otherwise removed from the patient'sface and open to atmospheric air, the flow is high and Pressure drops.As shown in graph 100 of FIG. 69, an illustrative blower 786 achieves140 liters per minute of air flow within about 3 to 3.5 seconds ofstartup. A curve fit formula for blower start up is shown in graph 1000.FIG. 70 includes a graph 1002 which compares the flow characteristicswhen mask 36 is properly delivering air to a patient's lungs (e.g.,illustrated by the lower curve of graph 1002) to the flowcharacteristics when mask 36 is open to atmosphere (i.e., illustrated inthe upper curve of graph 1002) over a much longer period of time than isshown in graph 1000 of FIG. 69. Thus, when the mask 36 is properlyconnected to a patient, the flow rate as measured by a flow sensor indevice 10 or device 10′ is at least 10 liters per minute less than whenthe mask 36 is removed from the patient and open to atmosphere. FIG. 71includes a graph 1004 which compares the flow characteristics when mask36 is removed from a patient (e.g., illustrated by the lower curve ofgraph 1004) to the flow characteristics when mask 36 is open toatmosphere (i.e., illustrated in the upper curve of graph 1004) over amuch longer period of time than is shown in graph 1000 of FIG. 69. Graph1004 shows that the flow characteristics after mask removal arebasically the same as those with open flow, as one would expect.

In connection with determining mask leakage, a similar algorithm isimplemented, but instead of step 3 comparing flow[n] to open flow,flow[n] is compared to some lesser number that indicates that maskleakage is too high. That mask leakage threshold, like the open_flowvalue, is dependent upon drive voltage (i.e., the voltage being used todrive blower 786). In the graphs of FIGS. 70 and 71, the scenario inwhich blower 786 is operating at maximum capacity is illustrated. Atmaximum capacity, therefore, blower 786 delivers about 140 liters perminute of air. If the blower is operating at a lower capacity, then theopen_flow and mask leakage threshold numbers of the above-describedalgorithm are adjusted accordingly. Such numbers may be determinedthrough experimentation or trial-and-error, for example, and then may beimplemented in software via an appropriate formula or via a look uptable.

Based on the preceding discussion of inspiratory trigger detection andmask removal/leakage detection, it should be understood that, in someembodiments, the inspiratory trigger is detected by control circuitry 76of devices 10, 10′ based on information sensed by at least one pressuresensor and at least one flow sensor, whereas mask leakage or removaldetection is detected by control circuitry 76 of devices 10, 10′ basedon information from the flow sensor only. In response to inspiratorytrigger detection, the pressure source (e.g., blower 786) or the valve(e.g., rotary valve 788) or both are operationally adjusted to provide adesired positive pressure to the patient's airway. Based on a flowsensor signal from the flow sensor, the controller 76 is configured todetermine mask removal or mask leakage and to stop operation of thepressure source. In some embodiments, the controller determines maskremoval or leakage by comparing the flow sensor signal to an open flowthreshold or a leakage threshold, respectively, on an iterative basis.For example, at least fifty iterations of flow sensor signal data pointcomparisons to the open flow threshold or the leakage threshold isrequired in the illustrative embodiment before the operation of thepressure source 786 is stopped. Each iteration takes about 5milliseconds in some embodiments.

Referring now to FIGS. 56-67, various screens that appear on graphicaluser interface (GUI) 16 to control functions of each of devices 10, 10′are shown. As shown in FIG. 56, a home screen 1010 of a respiratorydevice includes an Intrapulmonary Percussive Ventilation (IPV) icon 1012and a mechanical insufflation/exsufflation (MIE) 1014. If icon 1012 isselected on screen 1010, a positive pressure therapy screen 1016, shownin FIG. 57, results. If icon 1014 is selected on screen 1010, aninsufflation/exsufflation therapy screen 1018, shown in FIG. 59,results. Each of screens 1016, 1018 includes an automatic icon 1020, amanual icon 1022 and a graph icon 1024 as shown in FIGS. 57 and 59.

If graph icon 1024 is selected on screen 1016 or 1018, then a presetscreen 1026, shown in FIG. 58, results. Screen 1026 includes a menu 1028from which preset therapies can be selected. If screen 1026 is reachedfrom screen 1016, then the preset therapies in menu 1028 correspond topreset positive pressure therapies. On the other hand, if screen 1026 isreached from screen 1018, then the preset therapies in menu 1028correspond to preset insufflation/exsufflation therapies. The parametersof the preset therapies selectable on menu 1028 are programmed by usersof devices 10, 10′. Thus, target pressures (positive and/or negative),amplitude and frequency of pressure oscillations, time of therapy,inhalation time, exhalation time, pause time, and/or number of cycles oftherapy are among the parameters that are programmable by the user, forexample. During a preset therapy, these parameters may change from onenumerical value to another numerical value based on the programmingestablished by the user (e.g., patient or caregiver).

If automatic icon 1020 of screen 1018 of FIG. 59 is selected, then afirst automatic insufflation/exsufflation mode therapy screen 1030results as shown, for example, in FIG. 60. Screen 1030 is also exemplaryof a screen that results if one of the insufflation/exsufflation presetsis selected from menu 1028 of screen 1026. Screen 1030 includes a startbutton 1032 which is selected to start the associated MIE therapy, apause button 1034 which is selected to pause the associated MIE therapy,and a stop button 1036 which is selected to stop the associated MIEtherapy. Screen 1030 also has an information graph 1038 and aninformation bar 1040. Graph 1038 displays numerical parameters for theassociated therapy including inhale pressure, exhale pressure, inhaletime, exhale time, a therapy progress indicator which moves along thecurve shown in graph 1038 during the associated therapy, pause pressure,pause time, and a running total of the number of cycles completed duringthe associated therapy. Bar 1040 includes an upper arrow serving as aninhale pressure marker, a middle arrow serving as a pause pressuremarker, and a lower arrow serving as an exhale pressure marker. As shownin FIG. 61, if pause button 1034 is selected during delivery of MIEtherapy, an area 1042 of graph 1038 becomes filled or colored in amanner to indicate that point of the therapy at which the pause button1034 was selected.

If manual icon 1022 of screen 1018 of FIG. 59 is selected, then a firstmanual insufflation/exsufflation mode therapy screen 1044 results asshown, for example, in FIG. 62. Screen 1044 includes a start button 1046which is selected to start the associated MIE therapy and a stop button1048 which is selected to stop the associated MIE therapy. Screen 1044includes information bar 1040 which was discussed above. Screen 1044 hasan inhale button 1050 which is selected to cause positive pressure to bedelivered to the patient's airway by device 10, 10′ at a target positivepressure specified in a first window 1052. Screen 1044 also has anexhale button 1054 which is selected to cause negative pressure to bedelivered to the patient's airway by device 10, 10′ at a target negativepressure specified in a second window 1056.

Thus, during manual MIE mode, the user cyclically presses buttons 1050,1054, as desired, to deliver positive and negative pressure cyclicallyto the patient's airway. Buttons 1050, 1054 are lit up more brightly orbecome colored to indicate that they are active. The non-active one ofbuttons 1050, 1052 becomes grayed out until it is selected again by theuser. To pause the manual MIE therapy, a user double clicks on eitherbutton 1050 or button 1054 depending upon which is one is active at thetime. Up and down arrows are provided adjacent windows 1052, 1056 topermit the user to adjust the target pressures upwardly or downwardly.As shown in FIG. 63, a time of therapy window 1058 is provided toindicate the total amount of time that has transpired during the manualMIE therapy (e.g., 2 minutes, 38 seconds in the illustrative example).In some embodiments, one or more of screens 1030 of FIGS. 60 and 61 andscreens 1044 of FIGS. 62 and 63 have a flutter button that is pressed tocause the pressure to oscillate during delivery of automatic or manualMIE therapy. In some embodiments, the frequency of oscillation isadjustable such as with up and down arrows or with a numeric key pad asdescribed herein in connection with adjusting pressure settings ofdevices 10, 10′.

If automatic icon 1020 of screen 1016 of FIG. 57 is selected, then afirst automatic IPV mode therapy screen 1060 results as shown, forexample, in FIG. 64. Screen 1060 is also exemplary of a screen thatresults if one of the IPV presets is selected from menu 1028 of screen1026. Screen 1060 includes a start button 1062 which is selected tostart the associated IPV therapy, a pause button 1064 which is selectedto pause the associated IPV therapy, and a stop button 1066 which isselected to stop the associated IPV therapy. Screen 1060 also has aninformation graph 1068 and an information bar 1070. Illustrative graph1068 shows four stages of IPV therapy including a first stage of CPEPtherapy, a second stage of CHFO therapy at a first oscillatory amplitudeand/or frequency, a third stage of CHFO therapy at a second oscillatoryamplitude and/or frequency, and a fourth stage of CPEP therapy.

Graph 1068 displays numerical parameters for the associated therapyincluding CPEP pressure, CHFO pressure, time of CPEP stages, time ofCHFO stages, a therapy progress indicator which moves along the curveshown in graph 1068 during the associated therapy, and a running totaltime for the associated therapy. Bar 1070 includes an upper arrowserving as an peak pressure marker and a lower arrow serving as a meanpressure marker. As shown in FIG. 65, if pause button 1064 is selectedduring delivery of IPV therapy, an area 1072 of graph 1068 becomesfilled or colored in a manner to indicate that point of the therapy atwhich the pause button 1064 was selected.

If manual icon 1022 of screen 1016 of FIG. 57 is selected, then a firstmanual IPV mode therapy screen 1074 results as shown, for example, inFIG. 66. Screen 1074 includes a start button 1076 which is selected tostart the associated IPV therapy and a stop button 1078 which isselected to stop the associated IPV therapy. Screen 1074 includesinformation bar 1070 which was discussed above. Screen 1074 has a CPEPbutton 1080 which is selected to cause CPEP therapy to be delivered tothe patient's airway by device 10, 10′ at a selected target positivepressure specified in a first window 1082. Thus, for manual CPEPtherapy, the user first selects button 1080 to select CPEP and thenselects the start button 1076 to start the CPEP therapy. The user isable to adjust the target positive pressure in window 1082 by moving anicon along bar 1083 or by selecting up or down arrows adjacent to bar1083.

Screen 1074 also a CHFO button 1084 which is selected to cause CHFOtherapy to be delivered to the patient's airway by device 10, 10′ at aselected target positive pressure specified in a second window 1086 ofscreen 1074 and at a high, medium, or low frequency specified byselection of one of radio buttons 1088 as shown, for example, in FIG.67. Up and down arrows are provided adjacent window 1086 to permit theuser to adjust the CHFO target pressure upwardly or downwardly. As shownin FIGS. 64-67, a time of therapy window 1090 is provided to indicatethe total amount of time that has transpired during the CPEP therapy orthe CHFO therapy, as the case may be. As also shown in FIGS. 64-67, anebulizer icon 1092 is provided and is selected by the user if nebulizedmedication is to be delivered to the patient from a nebulizer during theCPEP or CHFO therapy. Screen 1010 of FIG. 56 also has nebulizer icon1092 which can be selected to start and stop delivery of nebulizedmedication by itself without MIE or IPV therapy also occurring.

CHFO therapy is a pneumatic form of chest physiotherapy that oscillatesthe airways with continuous pulses of positive pressure. CHFO therapycan be delivered from device 10, 10′ to mechanically ventilated patientswhen connected in-line with the mechanical ventilator, if desired. Insome embodiments, the frequencies associated with the high, medium, andlow radio buttons 1088 include about 5 hertz (Hz)+/−1 Hz (300+/−60 beatsper minute (bpm)) for the high frequency setting, about 4 Hz+/−1 Hz(240+/−60 bpm) for the medium frequency setting, and about 3 Hz+/−1 Hz(180+/−60 bpm) for the low frequency setting. Also, for CHFO therapy,device 10, 10′ is configured to deliver gas peak flow rate in the rangeof about 80 to about 160 liters per minute (L/min) at the output port ofhandset 900 in some embodiments. Further, for CHFO therapy, the peakstatic pressure is configurable over a range of about 10 cmH2O to 50cmH2O relative to ambient air pressure at the patient end of handset 900with +/−3 cmH2O of tolerance, in some embodiments.

CPEP therapy provides continuous positive pressure to the patient'sairway with the aim of holding open and expanding the patient's airway.During CPEP therapy, a static positive pressure is provided over a rangeof about 5 cmH2O to about 40 cmH2O relative to ambient air pressure atthe output of handset 900 with +/−3 cmH2O of tolerance, in someembodiments. Also during CPEP therapy, at the 40 cmH2O setting, the peakair flow rate delivered by device 10, 10′ is no less than 100 L/min insome embodiments. As indicated above, a nebulizer may be used witheither CPEP therapy or CHFO therapy. In some embodiments, the flow rateof delivery of the aerosolized medication from the nebulizer is at least0.2 milliliters per minute (mL/min).

In some embodiments, bar 1040 of FIGS. 60-63 and bar 1070 of FIGS. 64-67has a coloring over a portion of the bar to indicate, in substantiallyreal time, the pressure being delivered to port 24 of device 10, 10′.Thus, bars 1040, 1070 serve as dynamic or reactive digital monometers insome embodiments. In some embodiments, an information or “i” button isprovided on one or more of the screens of FIGS. 56-67 and is selectableto bring up textual information adjacent to each of the graphicalelements and buttons on the corresponding screen. The textualinformation explains the function or purpose of the adjacent graphicalelement or button. Screens 1030 of FIGS. 60 and 61 and screens 1060 ofFIGS. 64 and 65 have a progress bubble or circle that moves along theassociated pressure graph to indicate the point in the therapy regimenat which device 10, 10′ is currently operating. In screens 60 and 61,the progress bubble returns to the beginning of the graph for each cycleof the associated therapy.

In some embodiments, pause buttons 1034, 1064 toggle with theirassociated start buttons 1032, 1062 rather than being showing on thescreen simultaneously. That is, when start button 1032, 1062 is pressed,it becomes a pause button 1034, 1064 on the screen in the same locationon the screen. If the pause button 1034, 1064 is pressed, it togglesback to being a start button 1032, 1062. In some embodiments, a summaryscreen is provided after each of the therapies (i.e., automatic MIEtherapy, manual MIE therapy, automatic IPV therapy, and manual IPVtherapy). The summary screen indicates various parameters, such as meanpressure, number of cycles, oscillation frequency, and so on. Thesummary screens, in some embodiments, have a button that is pressed toperform a spirometry session with the patient. In such sessions, aspirometer is attached to port 816 of device 10′, for example, and thepatient breaths into the spirometer to generate a spirometry curve ofthe type shown in FIG. 27.

In some embodiments, rather than using up and down arrows to adjust anumerical setting appearing in a window (e.g., windows 1052, 1056, 1082,1086), the window itself can be selected and a numeric key pad willappear on display screen 16 so that a number can be entered directlyinto the window. In some embodiments, selection of an arrow tab at theright hand side of the screens of FIGS. 60-67 results in a menu of iconsbeing displayed on the right hand side of the screen. The icons include,for example, a home icon which is selected to go to a home page, adevice settings icon which is selected to adjust device settings, apreset icon which is selected to navigate to screens in which parametersfor the various preset therapies can be adjusted or edited, and advancedgraph icon which is selected to a more detailed graph of pressureoccurring during a therapy, and a help icon which is selected to obtainhelp about the operation of device 10, 10′.

Although certain illustrative embodiments have been described in detailabove, many embodiments, variations and modifications are possible thatare still within the scope and spirit of this disclosure as describedherein and as defined in the following claims.

What is claimed is:
 1. A respiratory device comprising a blower havingan inlet and an outlet, a patient interface, and a valve including avalve member that is rotatable through a first angular displacement in afirst direction from a first position to a second position, wherein theoutlet of the blower is coupled to the patient interface so thatpositive pressure is provided to a patient's airway via the patientinterface when the valve member is in the first position, wherein theinlet of the blower is coupled to the patient interface so that negativepressure is provided to the patient's airway via the patient interfacewhen the valve member is in the second position, wherein the valvemember is rotatably oscillated back and forth through a second angulardisplacement that is smaller than the first angular displacement in thefirst direction and a second direction opposite to the first directionwhen the valve member is in the first position and when the valve memberis in the second position so that oscillations in the positive pressureand negative pressure, respectively, are provided to the patient'sairway, wherein the valve member comprises a rotatable plate and thevalve comprises a pair of stationary plates between which the rotatableplate is sandwiched, wherein each of the stationary plates has fourholes, a center of each hole of the four holes being spaced from anothercenter of the four holes by about 90° around an axis about which therotatable plate rotates, and the rotatable plate has four holes groupedinto pairs of holes with a center of each hole of the pair of holesbeing spaced from a center of the other hole of the pair by about 45°around the axis.
 2. The respiratory device of claim 1, wherein the firstangular displacement is less than 90°.
 3. The respiratory device ofclaim 2, wherein the second angular displacement is about 10°.
 4. Therespiratory device of claim 1, wherein a frequency of oscillation of thevalve member is adjustable between about 1 Hertz and about 20 Hertz. 5.The respiratory device of claim 1, further comprising a stepper motorthat is operable to rotate and oscillate the valve member.
 6. Therespiratory device of claim 1, further comprising control circuitrycoupled to the blower and to the valve, a graphical user interface (GUI)coupled to the control circuitry, and one or more of the followingcoupled to the control circuitry: a port for connection to a wirelesscommunication module, a universal serial bus (USB) port, and a port forconnection to a pulse oximetry device.
 7. The respiratory device ofclaim 1, further comprising control circuitry coupled to the blower andto the valve and a graphical user interface (GUI) coupled to the controlcircuitry, the GUI being operable to display one or more of thefollowing: peak flow information, pressure information, flowinformation, volume information, a pressure graph, a volume graph, aflow graph, a flow vs. volume graph, and a pressure vs. time graph. 8.The respiratory device of claim 1, further comprising a wirelesscommunication module that is operable to transmit data wirelessly fromthe respiratory device.
 9. The respiratory device of claim 1, furthercomprising a port pneumatically coupled to the valve and an adapter thatinterconnects the port with a hose of the patient interface.
 10. Therespiratory device of claim 1, further comprising a housing containingthe blower, an outlet port accessible on the housing, at least onepressure sensor and at least one flow sensor to measure pressure andflow, respectively, in a flow path between the valve and the outletport, the patient interface comprising a tube having a first end coupledto the outlet port and a mask coupled to a second end of the tube, and acontroller receiving signals from the pressure sensor and the flowsensor to determine an inspiratory trigger indicative that the patienthas started to inhale, the pressure source or the valve or both beingoperationally adjusted in response to detection of the inspiratorytrigger, wherein based on a flow sensor signal from the flow sensor thecontroller is configured to determine mask removal or mask leakage andto stop operation of the blower.
 11. The respiratory device of claim 1,wherein the stationary plates between which the rotatable plate issandwiched each have circular outer peripheries.
 12. The respiratorydevice of claim 11, wherein the rotatable plate has a circular outerperiphery.
 13. The respiratory device of claim 12, wherein the valvecomprises an annular shim that is situated between the pair ofstationary plates and that surrounds the outer periphery of therotatable plate.
 14. The respiratory device of claim 11, wherein each ofthe four holes of each of the stationary plates is circular.
 15. Therespiratory device of claim 14, wherein the four holes of the rotatableplate are circular.
 16. The respiratory device of claim 1, wherein afirst plate of the pair of stationary plates has a first hole and asecond hole of its four holes pneumatically coupled to the inlet of theblower and has a third hole and fourth hole of its four holespneumatically coupled to the outlet of the blower.
 17. The respiratorydevice of claim 16, wherein when the rotatable plate is in the firstposition, a first hole of the four holes of the rotatable plate isaligned with the first hole of the first stationary plate and a solidportion of the rotatable plate blocks the second hole of the firststationary plate.
 18. The respiratory device of claim 17, wherein whenthe rotatable plate is in the second position, the first hole of thefirst stationary plate is blocked by another solid portion of therotatable plate and a second hole of the rotatable plate is aligned withthe second hole of the first stationary plate.
 19. The respiratorydevice of claim 17, wherein when the rotatable plate is in the firstposition a third hole of the rotatable plate is aligned with the thirdhole of the first stationary plate and another solid portion of therotatable plate blocks the fourth hole of the first stationary plate.20. The respiratory device of claim 19, wherein when the rotatable plateis in the second position, the third hole of the first stationary plateis blocked by yet another solid portion of the rotatable plate and afourth hole of the rotatable plate is aligned with the fourth hole ofthe first stationary plate.
 21. The respiratory device of claim 1,wherein a second plate of the pair of stationary plates has a first holeand a second hole of its four holes pneumatically coupled to the patientinterface and has a third hole and fourth hole of its four holespneumatically coupled to atmosphere.
 22. The respiratory device of claim21, wherein when the rotatable plate is in the first position, a firsthole of the four holes of the rotatable plate is aligned with the firsthole of the second stationary plate and a solid portion of the rotatableplate blocks the second hole of the second stationary plate.
 23. Therespiratory device of claim 22, wherein when the rotatable plate is inthe second position, the first hole of the second stationary plate isblocked by another solid portion of the rotatable plate and a secondhole of the rotatable plate is aligned with the second hole of thesecond stationary plate.
 24. The respiratory device of claim 22, whereinwhen the rotatable plate is in the first position a third hole of therotatable plate is aligned with the third hole of the second stationaryplate and another solid portion of the rotatable plate blocks the fourthhole of the second stationary plate.
 25. The respiratory device of claim24, wherein when the rotatable plate is in the second position, thethird hole of the second stationary plate is blocked by yet anothersolid portion of the rotatable plate and a fourth hole of the rotatableplate is aligned with the fourth hole of the second stationary plate.26. The respiratory device of claim 1, wherein a speed of the blower iscontrolled so that the positive pressure provided to the airway of thepatient substantially matches a positive target pressure selected by auser and so that the negative pressure provided to the airway of thepatient substantially matches a negative target pressure selected by theuser.
 27. The respiratory device of claim 26, wherein the blower speedis controlled so that a positive rest pressure, less than the positivetarget pressure, is provided to the airway of the patient after thenegative target pressure is applied to the airway of the patient andbefore the next positive target pressure is applied to the airway of thepatient.
 28. The respiratory device of claim 27, wherein the blowerspeed is controlled so that a sigh pressure is applied to the airway ofthe patient at the end of a therapy session, the sigh pressure beinggreater than the positive rest pressure but less than the positivetarget pressure.
 29. The respiratory device of claim 1, furthercomprising a sensor to sense a beginning of an inspiration of thepatient and control circuitry coupled to the sensor and to the valve,the control circuitry signaling the valve to move to the first positionin response to the sensor sensing the beginning of the inspiration ofthe patient, and the control circuitry signaling the blower to operateto provide the positive pressure to the airway of the patient at apositive target pressure.
 30. The respiratory device of claim 29,wherein the sensor comprises a pressure sensor or a flow sensor or both.31. The respiratory device of claim 29, wherein the control circuitry isprogrammable with a pause time during which sensing of the beginning ofan inspiration of the patient is ignored by the control circuitry andthe control circuitry signals the blower to operate to provide a restpressure to the airway of the patient, the rest pressure being apositive pressure that is less than the positive target pressure. 32.The respiratory device of claim 1, further comprising a housing in whichthe blower and valve are housed and a hose connector coupled to thehousing, the hose connector being configured to retain a hose of thepatient interface adjacent the housing when the patient interface is notin use.
 33. The respiratory device of claim 32, wherein the housingincludes a handle and the hose connector comprises a hook extending froma back of the handle.
 34. The respiratory device of claim 32, whereinthe housing includes a top wall and the hose connector comprises a hoseclip coupled to the top wall.
 35. The respiratory device of claim 34,further comprising a power cord extending from the housing and the hoseclip being configured as a cord wrap around which the power cord iswrapped when not in use.
 36. The respiratory device of claim 1, furthercomprising a housing in which the blower and valve are housed and acarrying case in which the housing fits, the carrying case having asection with a door that is openable to provide access to user controlson the housing without the need to remove the housing from the case. 37.The respiratory device of claim 36, wherein the door pivots upwardly ordownwardly from a closed position to an open position to expose the usercontrols for use.
 38. The respiratory device of claim 36, wherein thecarrying case is configured for attachment to a wheel chair.
 39. Therespiratory device of claim 1, wherein the valve includes a thirdstationary plate situated between the second stationary plate and therotatable plate and further comprising at least one spring situatedbetween the second stationary plate and the third stationary plate tobias the third stationary plate against the rotatable plate.
 40. Therespiratory device of claim 39, wherein the third stationary plate alsohas four holes and is formed to include four tubular portions, eachtubular portion being in registry with a respective hole of the fourholes of the second stationary plate.
 41. The respiratory device ofclaim 40, wherein the at least one spring comprises four springs, eachspring of the four springs being mounted on a respective tubular portionof the four tubular portions.
 42. The respiratory device of claim 39,wherein the second stationary plate includes an annular rim thatsurrounds a first outer periphery of the third stationary plate and asecond outer periphery of the rotatable plate.
 43. The respiratorydevice of claim 42, wherein the second stationary plate includes anannular flange projecting radially from the annular rim, the annularflange being fastened to the first stationary plate.
 44. The respiratorydevice of claim 1, further comprising a housing containing the blower,an outlet port accessible on the housing, the patient interface beingconfigured to be coupled to the outlet port, the patient interfaceincluding a filter housing that includes an air filter carrier and atleast one prong extending from the air filter carrier, and at least oneswitch situated in the housing, the housing having at least oneprong-receiving aperture adjacent the outlet port, the at least oneprong extending through the aperture and activating the switch when therespective patient interface is coupled to the outlet port, the pressuresource being disabled from operation unless the at least one switch isactivated.
 45. The respiratory device of claim 44, wherein the patientinterface comprises a first patient interface and a second patientinterface that is distinct and separate from the first patientinterface, wherein the at least one prong of the first patient interfacecomprises only one prong and the at least one prong of the secondpatient interface comprises two prongs.
 46. The respiratory device ofclaim 45, wherein the at least one switch comprises first and secondswitches and the at least one prong-receiving aperture comprises firstand second apertures, and further comprising a controller thatdistinguishes whether the first patient interface or the second patientinterface is coupled to the outlet port based on how many of the firstand second switches are activated.
 47. The respiratory therapy device ofclaim 1, wherein the patient interface includes a handset, the handsetcomprising a generally banana-shaped tube having an upper surface thatis generally convex from end-to-end of the generally banana-shaped tubeand a bottom surface that is generally concave from end-to-end of thegenerally banana-shaped tube, the generally banana-shaped tube havingopposite first and second open ends and having a nebulizer port that isprovided at an apex of the upper surface such that, in use, a nebulizerextends upwardly from a top of the handset.
 48. The respiratory deviceof claim 47, further comprising an aperture extending through thegenerally banana-shaped tube adjacent the first open end of thegenerally banana-shaped tube and a ring that is rotatable between afirst position in which the aperture is open to atmosphere and a secondposition in which the aperture is closed.